Clinical trial • Phase II • Oncology

VISUGROMAB for Non-small cell lung cancer (non-squamous, metastatic)

Phase II trial of VISUGROMAB for Non-small cell lung cancer (non-squamous, metastatic).

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Non-small cell lung cancer (non-squamous, metastatic)
Trial Stage: Phase II
Drug Modality: Monoclonal antibody|Small molecule|Other

Key dates

Initial CTIS Submission Date: 12-06-2025
First CTIS Authorization Date: 06-10-2025

Trial design

Randomised, docetaxel monotherapy (docetaxel iv, up to 75 mg/m2) administered with double placebo infusions (placebo = 0.9% sodium chloride); other arms include visugromab + nivolumab ± docetaxel (visugromab at rde or 6 mg/kg as specified).-controlled, crossover, adaptive Phase II trial in Germany, Italy, Romania and others.

Randomised: Yes
Comparator: Docetaxel monotherapy (docetaxel IV, up to 75 mg/m2) administered with double placebo infusions (placebo = 0.9% sodium chloride); other arms include visugromab + nivolumab ± docetaxel (visugromab at RDE or 6 mg/kg as specified).
Adaptive: True, IDMC review and interim analysis elements: after enrollment of 15 participants to visugromab at RDE across SRI and Arm A recruitment paused for 6 weeks follow-up for the last participant; IDMC analyzes cumulative interim safety and preliminary efficacy and decides on continuation with Part C. Safety Run-in with dose levels (Dose Level I and Dose Level II) to confirm safety/tolerability.
Crossover: Yes
Single Multiple Or Escalation Dose Combined: Yes
Target Sample Size: 131

Eligibility

Recruits 131 Vulnerable population flag selected. Participants must be ≥18 years and must be able to understand the purpose of the trial and provide voluntary signed and dated informed consent prior to any protocol procedures. Participants under legal guardianship are excluded. Assent is not applicable (no paediatric participants)..

Pregnancy Exclusion: Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial.
Vulnerable Population: Vulnerable population flag selected. Participants must be ≥18 years and must be able to understand the purpose of the trial and provide voluntary signed and dated informed consent prior to any protocol procedures. Participants under legal guardianship are excluded. Assent is not applicable (no paediatric participants).

Inclusion criteria

{"criterion_text":"- 1. Histologically or cytologically confirmed diagnosis of stage IV non squamous NSCLC.\n- 10. All toxicities attributable to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) or baseline before start of treatment.\n- 11. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to receiving the first dose of IMP.\n- 12. Females of childbearing potential must be willing to use a highly effective method of contraception from 14 days before the start of IMP and for the course of the trial through 150 days after the last dose of visugromab or nivolumab or through 180 days after last dose of chemotherapeutic agents as specified in the protocol, whatever comes later.\n- 13. Male participants with a female partner(s) of childbearing potential must agree to use a highly effective method of contraception, starting with the first dose of IMP through 150 days after last dose of visugromab or nivolumab, or through 180 days after last dose of chemotherapeutic agents as specified in the protocol, whatever comes later. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n- 14. Ability to understand the purpose of the trial and voluntary provision of a signed and dated informed consent prior to performing any protocol related procedures (including Screening evaluations) and ability to comply with the trial procedures (including completion of the electronic questionnaires on patient reported outcomes) and any locally required authorization.\n- 2. Demonstrated absence of actionable mutations (e.g. EGFR, ALK, among others) that suggest/require treatment with available targeted agent.\n- 3. Must have failed one line of prior systemic treatment for metastatic NSCLC containing an approved anti PD (L)1 CPI. The minimum treatment duration on this regimen must have been 12 weeks exposure for the CPI with no documented progression in this period. Failure of the prior line of systemic treatment for metastatic NSCLC must have occurred under ongoing CPI treatment. Discontinuation of the prior CPI and line of treatment due to AEs, or any other reason than progression/relapse does not permit enrollment.\n- 4. Participants should not have any contraindication to receive treatment with an anti-PD-(L)1 CPI or docetaxel.\n- 5. Measurable disease as per the local reading provided to the Investigator by a qualified radiologist based on assessment per RECIST v1.1. If a target lesion is located in a previously irradiated area, it will be considered measurable if progression (or non reduced size in the past 12 weeks) has been demonstrated in such a lesion post radiotherapy.\n- 6. Age ≥ 18 years on the day of signing the informed consent.\n- 7. Life expectancy of at least 3 months as assessed by the Investigator.\n- 8. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n- 9. Adequate organ function, defined as: Bone marrow function: Absolute neutrophil count (ANC) ≥ 1,500 /µL, Platelets ≥ 100,000 /µL, Hemoglobin ≥ 10.0 g/dL after ≥ 4 weeks without transfusions. Renal: Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2. Hepatic: Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN, Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN (or ≤ 5 × ULN for participants with liver metastases). Endocrine: Thyroid stimulating hormone (TSH) within normal range including participants with thyroid hormone substitution. If TSH is not within normal range at baseline, the participant will still be eligible if total T3 or free T3 and free T4 are within the normal range. Coagulation: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN unless the participant is receiving anticoagulant therapy, Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) ≤ 1.5 × ULN unless the participant is receiving anticoagulant therapy, No evidence for clinically relevant hypo- or hypercoagulability or presence of clinically relevant thrombosis/thrombotic event."}

Exclusion criteria

{"criterion_text":"- 1. Presence of predominantly squamous cell histology or predominantly neuroendocrine histology NSCLC (mixed tumors will be categorized by the predominant cell type) or presence of small cell lung cancer elements (ineligibility independent of percentage)."}
{"criterion_text":"- 19. Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes."}
{"criterion_text":"- 20. Chronic systemic corticosteroid treatment for other reasons. Participants with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections are not excluded from participation."}
{"criterion_text":"- 2. Currently participating in a clinical trial or receiving any investigational therapy or have participated in a trial of an investigational agent in the past 4 weeks or used an investigational device for any disease within 4 weeks prior to administration of any IMP."}
{"criterion_text":"- 21. Presence of active infection requiring systemic therapy."}
{"criterion_text":"- 22. Known history of Human Immunodeficiency Virus (HIV) infection (known HIV 1/2 antibodies [Ab] positive)."}
{"criterion_text":"- 23. Known active Hepatitis B or C. Active Hepatitis B is defined as a known positive HBsAg result. Active Hepatitis C is defined by a known positive IgM Hepatitis C Virus (HCV) antibody (Ab) result or known quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay."}
{"criterion_text":"- 24. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant’s participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator."}
{"criterion_text":"- 25. Symptomatic ascites or pleural effusion(s). A participant who is clinically stable following treatment for these conditions (including therapeutic fluid removal) is eligible."}
{"criterion_text":"- 26. Interstitial lung disease or a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis."}
{"criterion_text":"- 27. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial."}
{"criterion_text":"- 10. Received a live or live attenuated vaccination within 30 days of planned treatment start."}
{"criterion_text":"- 28. Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial (including severe alcoholism) or had a recent history (within the last 6 months before planned treatment start) of such abuse, or any other condition that as per Investigator view does not permit trial participation."}
{"criterion_text":"- 29. Participant is under legal guardianship."}
{"criterion_text":"- 3. Prior exposure to visugromab or another anti GDF 15 antibody or to docetaxel."}
{"criterion_text":"- 4. Received more than one line of prior systemic treatment for advanced/metastatic NSCLC."}
{"criterion_text":"- 5. Any acute or chronic major tissue injury that may require maintained GDF-15 function for tissue protection as per Investigator assessment (e.g., diagnosed with myocardial infarction, or liver, kidney, or other major organ failure, all within < 3 months prior to planned treatment start)."}
{"criterion_text":"- 6. Major surgery (defined as a surgery which requires general anesthetic and/or involves opening of body cavities), within 4 weeks of the first dose of IMP."}
{"criterion_text":"- 7. Received radiation therapy to the lung that is > 30 Gy within 6 months prior to the first dose of IMP."}
{"criterion_text":"- 8. Received or completed any focal radiotherapy for symptoms within 28 days of the first dose of IMP."}
{"criterion_text":"- 9. Expected to require any other form of antineoplastic therapy during the trial."}
{"criterion_text":"- 13. Known history of allogeneic tissue/solid organ transplant."}
{"criterion_text":"- 11. Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and/or gastrointestinal obstruction."}
{"criterion_text":"- 12. Known history of prior malignancy with the exception that the participant has undergone potentially curative therapy with a minimum of 5 years of complete remission prior to randomization, no evidence of disease recurrence and no further required therapy."}
{"criterion_text":"- 14. Known or detected clinically active central nervous system (CNS) involvement by NSCLC or other tumors, e.g., with symptomatic metastases and/or carcinomatous meningitis. Participants with CNS involvement may be enrolled with mandatory regular imaging of the brain as a site of disease if all CNS lesions fulfill one of the following criteria:- CNS lesions following prior focal radiotherapy or surgery: Clinically stable for at least 14 days post stereotactic radiotherapy, 14 days post whole brain irradiation, and at least 28 days post-surgery as documented by clinical assessment without evidence of new or enlarging brain metastases. Participants must be off steroids for 5 days prior to first dose of trial medication. - Known untreated, but asymptomatic CNS lesions (i.e., no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, no lesion >1.5 cm in diameter). - Clinically stable for at least 4 weeks before planned treatment start."}
{"criterion_text":"- 15. Have one of the following cardiovascular risk factors: Myocardial infarction in the past 3 months before planned treatment start, Uncontrolled heart failure, Uncontrolled ventricular arrhythmia, QT interval corrected for heart rate using Fridericia’s formula interval ≥ 470 ms regardless of sex, A peri/myocarditis in the past 3 months before planned treatment start, A history of ischemic stroke in the past 3 months before planned treatment start."}
{"criterion_text":"- 16. Prior severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)."}
{"criterion_text":"- 17. Known sensitivity to visugromab, nivolumab, and/or docetaxel and any component of these drug products."}
{"criterion_text":"- 18. An active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Local corticosteroid treatment or replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment."}

Endpoints

Primary endpoints

{"endpoint_text":"- Objective response rate (ORR), defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator at any time during the Core Trial Period.","definition_or_measurement_approach":"Defined as percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by the Investigator at any time during the Core Trial Period."}

Secondary endpoints

{"endpoint_text":"- 1. Incidence, type and severity of adverse events (AEs), recorded as treatment emergent adverse events (TEAEs), treatment related AEs (including immune mediated Adverse Events (imAEs) as AEs of Special Interest (AESIs)) and serious adverse events (SAEs).","definition_or_measurement_approach":"Recorded as TEAEs, treatment-related AEs (including imAEs as AESIs), and SAEs."}
{"endpoint_text":"- 2. Complete response (CR) rate.","definition_or_measurement_approach":""}
{"endpoint_text":"- 3. Partial response (PR) rate.","definition_or_measurement_approach":""}
{"endpoint_text":"- 4. Objective response rate (ORR).","definition_or_measurement_approach":""}
{"endpoint_text":"- 5. Duration of response (DOR).","definition_or_measurement_approach":""}
{"endpoint_text":"- 6. Time to response (TTR).","definition_or_measurement_approach":""}
{"endpoint_text":"- 7. Progression free survival (PFS).","definition_or_measurement_approach":""}
{"endpoint_text":"- 8. Overall survival (OS).","definition_or_measurement_approach":""}
{"endpoint_text":"- 9. Participant weight course over time.","definition_or_measurement_approach":""}
{"endpoint_text":"- 10. Maximum concentration (Cmax).","definition_or_measurement_approach":""}
{"endpoint_text":"- 11. Minimum concentration (Cmin).","definition_or_measurement_approach":""}
{"endpoint_text":"- 12. Participants’ subjective well-being as assessed via the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ).","definition_or_measurement_approach":"Assessed via the NSCLC-SAQ patient-reported instrument."}

Recruitment

Planned Sample Size: 131
Recruitment Window Months: 49
Consent Approach: Participants must provide voluntary signed and dated informed consent prior to any protocol-related procedures. Participants must be able to understand the purpose of the trial and comply with procedures (including completion of electronic patient-reported outcome questionnaires). Subject information and informed consent forms (SIS/ICF) are provided (country-specific versions available); lay synopses and ICFs exist in multiple languages (EN, ES, IT, PL, RO, BG as provided in the application documents). No assent processes (adult population ≥18 years).

Geography

Total Number Of Sites: 35
Total Number Of Participants: 103

Germany

Earliest CTIS Part Ii Submission Date: 26-08-2025
Latest Decision Or Authorization Date: 10-02-2026
Processing Time Days: 168
Number Of Sites: 7
Number Of Participants: 27

Sites

Site Name: Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
Department Name: Oncology
Principal Investigator Name: Karl-Otto Kambartel
Principal Investigator Email: kambartel@bethanienmoers.de
Contact Person Name: Karl-Otto Kambartel
Contact Person Email: kambartel@bethanienmoers.de

Site Name: Thoraxklinik Heidelberg gGmbH
Department Name: Thoracic Oncology
Principal Investigator Name: Helge Bischoff
Principal Investigator Email: helge.bischoff@med.uni-heidelberg.de
Contact Person Name: Helge Bischoff
Contact Person Email: helge.bischoff@med.uni-heidelberg.de

Site Name: LungenClinic Grosshansdorf GmbH
Principal Investigator Name: Martin Reck
Principal Investigator Email: M.Reck@lungenclinic.de
Contact Person Name: Martin Reck
Contact Person Email: M.Reck@lungenclinic.de

Site Name: Evangelisches Klinikum Bethel gGmbH
Department Name: Internal Medicine, Haematology / Oncology
Principal Investigator Name: Florian Weissinger
Principal Investigator Email: florian.weissinger@evkb.de
Contact Person Name: Florian Weissinger
Contact Person Email: florian.weissinger@evkb.de

Site Name: KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name: Internal Medicine and Oncology
Principal Investigator Name: Konstantinos Ferentinos
Principal Investigator Email: k.ferentinos@kem-med.com
Contact Person Name: Konstantinos Ferentinos
Contact Person Email: k.ferentinos@kem-med.com

Site Name: Klinikum Esslingen GmbH
Department Name: Clinic for Cardiology, Angiology and Pneumology
Principal Investigator Name: Martin Faehling
Principal Investigator Email: m.faehling@klinikum-esslingen.de
Contact Person Name: Martin Faehling
Contact Person Email: m.faehling@klinikum-esslingen.de

Site Name: Universitaetsklinikum Wuerzburg AöR
Department Name: Interdisciplinary Study Center with Early Clinical Trial Unit
Principal Investigator Name: Maria-Elisabeth Goebeler
Principal Investigator Email: Goebeler_m@ukw.de
Contact Person Name: Maria-Elisabeth Goebeler
Contact Person Email: Goebeler_m@ukw.de

Italy

Earliest CTIS Part Ii Submission Date: 05-09-2025
Latest Decision Or Authorization Date: 12-02-2026
Processing Time Days: 160
Number Of Sites: 7
Number Of Participants: 17

Sites

Site Name: I.F.O. Istituti Fisioterapici Ospitalieri
Department Name: Phase 1 Clinical Center
Principal Investigator Name: Gabriele Minuti
Principal Investigator Email: gabriele.minuti@ifo.it
Contact Person Name: Gabriele Minuti
Contact Person Email: gabriele.minuti@ifo.it

Site Name: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name: Unit of Thoracic Oncology
Principal Investigator Name: Angelo Delmonte
Principal Investigator Email: angelo.delmonte@irst.emr.it
Contact Person Name: Angelo Delmonte
Contact Person Email: angelo.delmonte@irst.emr.it

Site Name: Centro Di Riferimento Oncologico Di Aviano
Department Name: The Medical and Immune-related Tumor Oncology
Principal Investigator Name: Brigida Stanzione
Principal Investigator Email: brigida.stanzione@cro.it
Contact Person Name: Brigida Stanzione
Contact Person Email: brigida.stanzione@cro.it

Site Name: Istituto Europeo Di Oncologia S.r.l.
Department Name: Thoracic Oncology Division
Principal Investigator Name: Filippo De Marinis
Principal Investigator Email: filippo.demarinis@ieo.it
Contact Person Name: Filippo De Marinis
Contact Person Email: filippo.demarinis@ieo.it

Site Name: Azienda Unita Sanitaria Locale Della Romagna
Department Name: Onco-Hematology
Principal Investigator Name: Manolo D'Arcangelo
Principal Investigator Email: manolo.darcangelo@auslromagna.it
Contact Person Name: Manolo D'Arcangelo
Contact Person Email: manolo.darcangelo@auslromagna.it

Site Name: Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name: Medical Oncology Unit 1
Principal Investigator Name: Giuseppe Lo Russo
Principal Investigator Email: giuseppe.lorusso@istitutotumori.mi.it
Contact Person Name: Giuseppe Lo Russo
Contact Person Email: giuseppe.lorusso@istitutotumori.mi.it

Site Name: Istituto Europeo Di Oncologia S.r.l.
Department Name: Thoracic Oncology Division
Principal Investigator Name: Filippo De Marinis
Principal Investigator Email: filippo.demarinis@ieo.it
Contact Person Name: Filippo De Marinis
Contact Person Email: filippo.demarinis@ieo.it

Romania

Earliest CTIS Part Ii Submission Date: 02-07-2025
Latest Decision Or Authorization Date: 16-02-2026
Processing Time Days: 229
Number Of Sites: 3
Number Of Participants: 9

Sites

Site Name: Oncomed S.R.L.
Department Name: Oncology
Principal Investigator Name: Daniela Elvira Sirbu
Principal Investigator Email: desirbu@yahoo.com
Contact Person Name: Daniela Elvira Sirbu
Contact Person Email: desirbu@yahoo.com

Site Name: Centrul De Oncologie SF Nectarie S.R.L.
Department Name: Oncology
Principal Investigator Name: Michael Schenker
Principal Investigator Email: mike_schenker@yahoo.com
Contact Person Name: Michael Schenker
Contact Person Email: mike_schenker@yahoo.com

Site Name: Clinica Polisano S.R.L.
Department Name: Oncology (Str. Izvorului 1A, 550172, Sibiu, Romania)
Principal Investigator Name: Victor Nimirceag
Principal Investigator Email: Dr.Nimirceag@gmail.com
Contact Person Name: Victor Nimirceag
Contact Person Email: Dr.Nimirceag@gmail.com

Spain

Earliest CTIS Part Ii Submission Date: 05-09-2025
Latest Decision Or Authorization Date: 20-02-2026
Processing Time Days: 168
Number Of Sites: 15
Number Of Participants: 41

Sites

Site Name: Hospital Universitario De Jaen
Department Name: Medical Oncology
Principal Investigator Name: Jose Antonio Lopez Lopez
Principal Investigator Email: Jall92hs@gmail.com
Contact Person Name: Jose Antonio Lopez Lopez
Contact Person Email: Jall92hs@gmail.com

Site Name: Hospital Clinic De Barcelona
Department Name: Medical Oncology
Principal Investigator Name: Laura Mezquita Perez
Principal Investigator Email: lmezquita@clinic.cat
Contact Person Name: Laura Mezquita Perez
Contact Person Email: lmezquita@clinic.cat

Site Name: Hospital Universitario Lucus Augusti
Department Name: Medical Oncology
Principal Investigator Name: Sergio Vazquez Estevez
Principal Investigator Email: sergio.vazquez.estevez@sergas.es
Contact Person Name: Sergio Vazquez Estevez
Contact Person Email: sergio.vazquez.estevez@sergas.es

Site Name: Hospital Universitari Dexeus Grupo Quironsalud
Department Name: Medical Oncology
Principal Investigator Name: Andrés Aguilar Hernández
Principal Investigator Email: aaguilar@oncorosell.com
Contact Person Name: Andrés Aguilar Hernández
Contact Person Email: aaguilar@oncorosell.com

Site Name: Fundacion Rioja Salud
Department Name: Medical Oncology
Principal Investigator Name: María de Miguel
Principal Investigator Email: maria.demiguel@startrioja.com
Contact Person Name: María de Miguel
Contact Person Email: maria.demiguel@startrioja.com

Site Name: Hospital Universitario Hm Sanchinarro
Department Name: Medical Oncology
Principal Investigator Name: Gema García Ledo
Principal Investigator Email: gmgarcialedo@hmhospitales.com
Contact Person Name: Gema García Ledo
Contact Person Email: Jall92hs@gmail.com

Site Name: Complexo Hospitalario Universitario De Santiago
Department Name: Medical Oncology
Principal Investigator Name: Luis Angel Leon Mateos
Principal Investigator Email: luis.angel.leon.mateos@sergas.es
Contact Person Name: Luis Angel Leon Mateos
Contact Person Email: luis.angel.leon.mateos@sergas.es

Site Name: Hospital Universitari De Girona Doctor Josep Trueta
Department Name: Medical Oncology
Principal Investigator Name: Joaquim Bosch Barrera
Principal Investigator Email: jbosch@iconcologia.net
Contact Person Name: Joaquim Bosch Barrera
Contact Person Email: jbosch@iconcologia.net

Site Name: Hospital Universitario 12 De Octubre
Department Name: Medical Oncology
Principal Investigator Name: Luis Gonzaga Paz-Ares Rodrigues
Principal Investigator Email: luis.paz-ares@salud.madrid.org
Contact Person Name: Luis Gonzaga Paz-Ares Rodrigues
Contact Person Email: luis.paz-ares@salud.madrid.org

Site Name: University Hospital Virgen Del Rocio S.L.
Department Name: Medical Oncology
Principal Investigator Name: Amparo Sánchez Gastaldo
Principal Investigator Email: asanchezgastaldo@gmail.com
Contact Person Name: Amparo Sánchez Gastaldo
Contact Person Email: asanchezgastaldo@gmail.com

Site Name: Clinica Universidad De Navarra (Madrid)
Department Name: Medical Oncology
Principal Investigator Name: Miguel Fernández de Sanmamed Gutiérrez
Principal Investigator Email: msanmamed@unav.es
Contact Person Name: Miguel Fernández de Sanmamed Gutiérrez
Contact Person Email: msanmamed@unav.es

Site Name: Clinica Universidad De Navarra (Pamplona)
Department Name: Medical Oncology
Principal Investigator Name: Miguel Fernández de Sanmamed Gutiérrez
Principal Investigator Email: msanmamed@unav.es
Contact Person Name: Miguel Fernández de Sanmamed Gutiérrez
Contact Person Email: msanmamed@unav.es

Site Name: MD Anderson Cancer Center (Madrid)
Department Name: Medical Oncology
Principal Investigator Name: Fernando Fabio Franco Pérez
Principal Investigator Email: ffranco@fundacionmdanderson.es
Contact Person Name: Fernando Fabio Franco Pérez
Contact Person Email: ffranco@fundacionmdanderson.es

Site Name: Hospital Universitario Regional De Malaga
Department Name: Medical Oncology
Principal Investigator Name: Manuel Cobo Dols
Principal Investigator Email: manuelcobodols@yahoo.es
Contact Person Name: Manuel Cobo Dols
Contact Person Email: manuelcobodols@yahoo.es

Site Name: Hospital Universitari Vall D Hebron
Department Name: Medical Oncology
Principal Investigator Name: Enriqueta Felip Fort
Principal Investigator Email: efelip@vhio.net
Contact Person Name: Enriqueta Felip Fort
Contact Person Email: efelip@vhio.net

Poland

Earliest CTIS Part Ii Submission Date: 02-07-2025
Latest Decision Or Authorization Date: 16-02-2026
Processing Time Days: 229
Number Of Sites: 3
Number Of Participants: 9

Sites

Site Name: Szpital Specjalistyczny W Prabutach Sp. z o.o.
Department Name: Oddział Pulmonologii
Principal Investigator Name: Anna Łowczak
Principal Investigator Email: onkoania@gazeta.pl
Contact Person Name: Anna Łowczak
Contact Person Email: onkoania@gazeta.pl

Site Name: Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name: Oddział Wieloprofilowy Zachowawczy
Principal Investigator Name: Izabela Chmielewska
Principal Investigator Email: izachm@wp.pl
Contact Person Name: Izabela Chmielewska
Contact Person Email: izachm@wp.pl

Site Name: Med Polonia Sp. z o.o.
Department Name: Med-Polonia Spółka z Ograniczoną Odpowiedzialnością
Principal Investigator Name: Rodryg Ramlau
Principal Investigator Email: rramlau@gmail.com
Contact Person Name: Rodryg Ramlau
Contact Person Email: rramlau@gmail.com

Sponsor

Primary sponsor

Full Name: CatalYm GmbH
Organisation Type: Pharmaceutical company
Country Of Registered Address: Germany

Contract research organisations

Name: Psi Cro AG
Responsibilities: Clinical operations / CRO functions (codes: 1,12,2,5 as listed in sponsor duties)

Name: Metronomia Clinical Research GmbH
Responsibilities: Clinical operations / project management (codes: 10,11,6,7)

Name: Primevigilance Limited
Responsibilities: Pharmacovigilance

Third parties

{"country":"Switzerland","full_name":"Lonza AG","duties_or_roles":"Drug Substance: Release Testing (Polysorbate), Stability Testing (Polysorbate); Drug Product: Release Testing, Stability Testing","organisation_type":"Pharmaceutical company"}
{"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"Codes: 1,12,2,5","organisation_type":"Pharmaceutical company"}
{"country":"Germany","full_name":"Fisher Clinical Services GmbH (Rheinfelden)","duties_or_roles":"Drug Product: QP Release, Distribution","organisation_type":"Pharmaceutical company"}
{"country":"Switzerland","full_name":"Fisher Clinical Services GmbH (Allschwil)","duties_or_roles":"Drug Product: Secondary packaging, Labelling","organisation_type":"Pharmaceutical company"}
{"country":"Germany","full_name":"Fisher Clinical Services GmbH (Weil Am Rhein)","duties_or_roles":"Decommissioning","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"Pharmacovigilance","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Bioreliance Limited (Penicuik)","duties_or_roles":"Drug Substance: Release Testing, Stability Testing","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"Laboratory/testing services (code 4)","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Bioreliance Corp.","duties_or_roles":"Drug Substance: Release Testing, Stability Testing","organisation_type":"Pharmaceutical company"}
{"country":"France","full_name":"Eurofins Adme Bioanalyses","duties_or_roles":"Bioanalysis (code 4)","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Lonza Biologics Inc.","duties_or_roles":"Drug Substance: Cell bank storage","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"Drug Product: Secondary packaging, Labelling","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Metabolon Inc.","duties_or_roles":"Laboratory services (code 4)","organisation_type":"Pharmaceutical company"}
{"country":"Germany","full_name":"Metronomia Clinical Research GmbH","duties_or_roles":"Codes: 10,11,6,7 (clinical operations related functions)","organisation_type":"Pharmaceutical company"}
{"country":"Switzerland","full_name":"Lonza AG (Stein Ag)","duties_or_roles":"Drug Product: Manufacturing, Primary Packaging, Release Testing (microbiologic), Stability storage","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Bioreliance Limited (Glasgow)","duties_or_roles":"Drug Substance: Release Testing, Stability Testing","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Alderley Analytical Limited","duties_or_roles":"Analytical services (code 4)","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Bioreliance Limited (Todd Campus)","duties_or_roles":"Drug Substance: Release Testing, Stability Testing","organisation_type":"Pharmaceutical company"}
{"country":"Germany","full_name":"Metronomia Clinical Research GmbH","duties_or_roles":"Clinical operations / project management (codes:10,11,6,7)","organisation_type":"Pharmaceutical company"}
{"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"Laboratory services (code 4)","organisation_type":"Pharmaceutical company"}
{"country":"France","full_name":"Solvias France","duties_or_roles":"Drug Product: Stability Testing (sterility), Release Testing (sterility)","organisation_type":"Pharmaceutical company"}
{"country":"Germany","full_name":"Mlm Medical Labs GmbH","duties_or_roles":"Laboratory Kit Supply, Sample Management & Triage","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"France","full_name":"Median Technologies","duties_or_roles":"Central Imaging","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Bioreliance Limited (Portsmouth)","duties_or_roles":"Drug Substance: Release Testing, Stability Testing","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Lonza Biologics PLC","duties_or_roles":"Drug Substance: cell bank storage, Manufacturing, Primary Packaging, Release Testing, Stability Testing; Drug Product: Stability Testing (potency)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name: Visugromab (CTL-002)
Active Substance: VISUGROMAB
Modality: Monoclonal antibody
Routes Of Administration: INTRAVENOUS USE
Route: Intravenous
Authorisation Status: prodAuthStatus:1
Dose Levels: Dose Level I; Dose Level II (one specified dose: 6 mg/kg in Arm B; RDE used in Arm A/C)
Maximum Dose: 20 mg/kg (maxDailyDoseAmount as provided)

Investigational Product Name: NIVOLUMAB
Active Substance: NIVOLUMAB
Modality: Monoclonal antibody
Routes Of Administration: INTRAVENOUS USE
Route: Intravenous
Authorisation Status: prodAuthStatus:2
Maximum Dose: 360 mg/kg (maxDailyDoseAmount as provided)

Investigational Product Name: DOCETAXEL
Active Substance: DOCETAXEL
Modality: Small molecule
Routes Of Administration: INTRAVENOUS USE
Route: Intravenous
Authorisation Status: prodAuthStatus:2
Maximum Dose: 75 mg/m2 (maxDailyDoseAmount as provided)

Investigational Product Name: SODIUM CHLORIDE (placebo)
Active Substance: SODIUM CHLORIDE
Modality: Other
Routes Of Administration: INTRAVENOUS USE
Route: Intravenous
Authorisation Status: prodAuthStatus:2
Maximum Dose: 0.9% (W/V)

Combination Treatment: Yes

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