Clinical trial • Phase I • Oncology

N-(4-FLUOROPHENYL)-N-(4-((7-METHOXY-6-(METHYLCARBAMOYL)QUINOLIN-4-YL)OXY)PHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE for Clear cell renal cell carcinoma | Metastatic castration-resistant prostate cancer | Urothelial carcinoma | Non-clear cell renal cell carcinoma | Colorectal cancer | Hepatocellular carcinoma | Non-small cell lung cancer | Head and neck squamous cell carcinoma

Phase I trial of N-(4-FLUOROPHENYL)-N-(4-((7-METHOXY-6-(METHYLCARBAMOYL)QUINOLIN-4-YL)OXY)PHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE for Clear cell renal cell…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Clear cell renal cell carcinoma | Metastatic castration-resistant prostate cancer | Urothelial carcinoma | Non-clear cell renal cell carcinoma | Colorectal cancer | Hepatocellular carcinoma | Non-small cell lung cancer | Head and neck squamous cell carcinoma
Trial Stage
Phase I
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
12-02-2024
First CTIS Authorization Date
28-03-2024

Trial design

open-label, adaptive Phase I trial in Austria, Italy, Germany and others.

Open Label
Yes
Adaptive
True, Dose-escalation stage to determine recommended dose (RD) for combination therapies and subsequent initiation of tumor-specific expansion cohorts once RD established; specific escalation rules not provided in CTIS metadata.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
572

Eligibility

Recruits 572 Vulnerable population selection is indicated (isVulnerablePopulationSelected=true). Participants must be able to understand and comply with protocol requirements and must sign informed consent; exclusion criteria include psychiatric illness likely to interfere with ability to comply or give informed consent. Consent/ICF documents and partner/pregnancy information forms are provided (multiple language versions)..

Pregnancy Exclusion
15. Pregnant or lactating females.
Vulnerable Population
Vulnerable population selection is indicated (isVulnerablePopulationSelected=true). Participants must be able to understand and comply with protocol requirements and must sign informed consent; exclusion criteria include psychiatric illness likely to interfere with ability to comply or give informed consent. Consent/ICF documents and partner/pregnancy information forms are provided (multiple language versions).

Inclusion criteria

  • {"criterion_text":"- 1. Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic: Dose-Escalation Stage: a. Subjects with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective. Expansion Stage: The tumor cohorts are: Cohort 1: ccRCC (1L); Cohort 2: ccRCC (2L); Cohort 3: mCRPC (post 1 NHT); Cohort 4: UC ICI-naïve; Cohort 5: UC ICI-experienced; Cohort 6: nccRCC (1L); Cohort 7: HCC (1L); Cohort 8: NSCLC (PD-L1 low TPS 149%, 1L); Cohort 9: NSCLC (2L+; Cohort 10: CRC (MSS, 2L or 3L and beyond); Cohort 11: HNSCC (ICI-naïve); Cohort 12: ccRCC (2-3L); Cohort 13: ccRCC (1L) - please refer to protocol for additional details on inclusion criteria for specific Cohorts."}
  • {"criterion_text":"- 10. Female subjects of childbearing potential must not be pregnant at screening."}
  • {"criterion_text":"- 2. For all expansion cohorts except Cohort 3 measurable disease per RECIST 1.1 (Eisenhauer et al 2009) as determined by the Investigator with exception of mCRPC."}
  • {"criterion_text":"- 3. For expansion cohorts 1-11 only: archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained."}
  • {"criterion_text":"- 4. Recovery to baseline or ≤ Grade 1 CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy."}
  • {"criterion_text":"- 5. Age 18 years or older on the day of consent."}
  • {"criterion_text":"- 6. Karnofsky Performance Status (KPS) ≥ 70%."}
  • {"criterion_text":"- 7. Adequate organ and marrow function."}
  • {"criterion_text":"- 8. Capable of understanding and complying with the protocol requirements and must have signed the informed consent form."}
  • {"criterion_text":"- 9. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and for the following durations after the last dose of treatment (whichever is later)."}

Exclusion criteria

  • {"criterion_text":"- 1. For all Dose-Escalation Cohorts: Prior treatment with zanzalintinib. For all Expansion Cohorts: Prior treatment with zanzalintinib, nivolumab, ipilimumab, or relatlimab with some exceptions."}
  • {"criterion_text":"- 18. Any other active malignancy within two years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6."}
  • {"criterion_text":"- 2. For Dose-Escalation Cohorts and Cohort 2 (ccRCC 2L), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC, 2L+), Cohort 10 (CRC, 2L or 3L and beyond) and Cohort 12 (ccRCC 2-3L): Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment."}
  • {"criterion_text":"- 3. For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment."}
  • {"criterion_text":"- 4. For all Dose-Escalation Cohorts and Cohort 2 (ccRCC 2L), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC (2L+), Cohort 10 (CRC, 2L or 3L and beyond+), and Cohort 12 (ccRCC 2-3L): Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before first dose of study treatment."}
  • {"criterion_text":"- 5. Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment."}
  • {"criterion_text":"- 6. Prior radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment unless otherwise specified."}
  • {"criterion_text":"- 7. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment."}
  • {"criterion_text":"- 8. Concomitant anticoagulation with oral anticoagulants with some exceptions (refer to protocol)"}
  • {"criterion_text":"- 9. Administration of a live, attenuated vaccine 30 days prior to first dose."}
  • {"criterion_text":"- 19. Other conditions, which in the opinion of the investigator or Sponsor, would compromise the safety of the subject’s ability to complete the study. Please refer to the protocol for detailed cohort specific exclusion criteria"}
  • {"criterion_text":"- 10. Uncontrolled, significant intercurrent or recent illness."}
  • {"criterion_text":"- 11. Major surgery within 8 weeks prior to first dose. Prior laparoscopic nephrectomy within 4 weeks prior to first dose. Minor surgery (eg, simple excision, tooth extraction) within 10 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose."}
  • {"criterion_text":"- 12. Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms for females and > 450 ms for males per electrocardiogram (ECG) within 14 days before first dose of study treatment. Furthermore, subjects must not have family history of sudden cardiac death before age 50, heart disease, history of arrhythmia, bradycardia defined as < 50 beats per minute, or acute neurologic events within 6 months prior to inclusion."}
  • {"criterion_text":"- 13. Subjects with inadequately treated adrenal insufficiency."}
  • {"criterion_text":"- 14. History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent"}
  • {"criterion_text":"- 15. Pregnant or lactating females."}
  • {"criterion_text":"- 16. Inability to swallow tablets or ingest a suspension either orally or by a nasogastric or gastrostomy tube."}
  • {"criterion_text":"- 17. Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions (IRRs) to monoclonal antibodies."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Dose-Escalation Stage (Zanzalintinib Combination Therapy): - Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including immune-mediated adverse events (imAEs)","definition_or_measurement_approach":"Incidence and severity of AEs and SAEs, including immune-mediated adverse events (imAEs); no additional measurement definition provided in the CTIS record."}
  • {"endpoint_text":"- Expansion Stage (Zanzalintinib Monotherapy and Combination Therapy): - Objective Response Rate (ORR) in subjects with measurable disease as assessed by the Investigator per RECIST 1.1","definition_or_measurement_approach":"ORR assessed by the Investigator according to RECIST 1.1."}
  • {"endpoint_text":"- For Cohort 3 (mCRPC): duration of radiographic PFS as determined per Prostate Working Group 3 (PCWG3) criteria (Scher et al 2016) by Blinded Independent Radiology Committee (BIRC)","definition_or_measurement_approach":"Radiographic progression-free survival determined per PCWG3 criteria by BIRC."}
  • {"endpoint_text":"- For Cohort 10 (CRC): Overall survival (OS) rate at 6 months.","definition_or_measurement_approach":"Overall survival rate measured at 6 months (OS at 6 months)."}
  • {"endpoint_text":"- Incidence and severity of nonserious AEs and SAEs, including imAEs","definition_or_measurement_approach":"Incidence and severity of nonserious adverse events and SAEs, including immune-mediated AEs; no further specification in the CTIS record."}

Secondary endpoints

  • {"endpoint_text":"- Expansion Stage (Zanzalintinib Monotherapy and Combination Therapy): • DOR based on assessment by the Investigator per RECIST 1.1","definition_or_measurement_approach":"Duration of response (DOR) assessed by the Investigator per RECIST 1.1."}
  • {"endpoint_text":"- • PFS for subjects with measurable disease as assessed by the Investigator per RECIST 1.1","definition_or_measurement_approach":"Progression-free survival (PFS) assessed by Investigator per RECIST 1.1."}
  • {"endpoint_text":"- • For Cohort 3 (mCRPC): o Proportion of subjects achieving a > 50% decrease in prostate-specific antigen (PSA) from baseline confirmed by a second consecutive PSA assessment at least 3 weeks later o Change in bone biomarkers - Duration of radiographic PFS as determined by Investigator per PCWG3 criteria (Scher et al 2016)","definition_or_measurement_approach":"For mCRPC: proportion with >50% PSA decline confirmed by a second assessment ≥3 weeks later; change in bone biomarkers; radiographic PFS per PCWG3 as determined by Investigator."}
  • {"endpoint_text":"- • ORR, DOR, and PFS for subjects with measurable disease as assessed by a BIRC per RECIST 1.1 for selected cohorts as determined by the Sponsor","definition_or_measurement_approach":"ORR, DOR and PFS assessed by a Blinded Independent Radiology Committee (BIRC) per RECIST 1.1 for selected cohorts."}
  • {"endpoint_text":"- • Overall survival (OS)","definition_or_measurement_approach":"Overall survival measured as time-to-event (no further detail in CTIS record)."}
  • {"endpoint_text":"- • Concentration of study treatments (zanzalintinib, nivolumab, ipilimumab and relatlimab) in plasma or serum at different timepoints","definition_or_measurement_approach":"Pharmacokinetic measurements: plasma/serum concentrations of study treatments at specified timepoints (details in protocol)."}
  • {"endpoint_text":"- • Change in tumor and blood biomarkers","definition_or_measurement_approach":"Assessment of tumor and blood biomarkers (specific biomarkers and assays referenced in protocol/documents)."}
  • {"endpoint_text":"- • The number and percentage of subjects who develop ADA response to nivolumab, ipilimumab or relatlimab","definition_or_measurement_approach":"Immunogenicity: number and percent with anti-drug antibody (ADA) responses to nivolumab, ipilimumab or relatlimab."}

Recruitment

Digital Remote Recruitment
True, digital methods include Dr-to-Dr WhatsApp leaflet for clinician-to-clinician outreach and DTP flyers (electronic distribution implied) listed in country-specific recruitment materials.
Planned Sample Size
572
Recruitment Window Months
95
Consent Approach
Informed consent required and must be signed by the participant; participants must be capable of understanding and complying with protocol requirements (inclusion criterion). Study-specific informed consent forms and subject information sheets are provided in multiple languages (examples in CTIS documents: German, Italian, Spanish, Polish, French, Dutch and English versions of Main Expansion ICF / SIS-ICF and partner/pregnancy forms). Exclusion criteria include psychiatric illness likely to interfere with ability to give informed consent.

Methods

  • HCP-targeted recruitment materials (HCP brochures, HCP recruitment leaflets) - country-specific HCP materials listed (e.g. K2_* HCP Recruitment Brochure/Leaflet files).
  • Physician referral letters (template physician referral letters listed for countries) to enable site-to-site/physician referrals.
  • Direct-to-patient (DTP) flyers and DTP campaigns (DTP flyers present in multiple languages among recruitment materials).
  • Dr-to-Dr WhatsApp leaflet (document listed for Italy indicating use of WhatsApp messaging between clinicians as part of outreach).
  • Country-specific recruitment procedures (K1_* Recruitment Procedure documents for Austria, Italy, Germany, Belgium, Spain, Poland, France present).

Geography

Total Number Of Sites
55
Total Number Of Participants
407

Austria

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
487
Number Of Sites
3
Number Of Participants
19

Sites

Site Name
University Hospital Graz
Department Name
Department of Internal Medicine
Contact Person Name
Thomas Bauernhofer
Site Name
Krankenhaus Der Barmherzigen Brueder Wien
Department Name
Department of Internal Medicine Hospital Barmherzige Brueder Vienna
Contact Person Name
Johannes Gobertus Meran
Contact Person Email
johannes.meran@bbwien.at
Site Name
Medical University Of Vienna
Department Name
Department of Urology
Contact Person Name
Manuela Schmidinger

Italy

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
02-07-2025
Processing Time Days
482
Number Of Sites
7
Number Of Participants
72

Sites

Site Name
Careggi University Hospital
Department Name
SODc Oncologia Medica e Clinica
Contact Person Name
Lorenzo Antonuzzo
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Medical Oncology
Contact Person Name
Rossana Berardi
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Dipartimento di ricercar traslazionale supporto dei percorsi oncologici
Contact Person Name
Adriano Gravina
Contact Person Email
a.gravina@istitutotumori.na.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Oncology-Hematology Department
Contact Person Name
Francesco Carrozza
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Oncology Department
Contact Person Name
Stefania Salvagni
Contact Person Email
stefania.salvagni@aosp.bo.it
Site Name
European Institute Of Oncology S.r.l.
Department Name
Division of Early Drug Development
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Department of Medical Oncology
Contact Person Name
Andrea Necchi
Contact Person Email
necchi.andrea@hsr.it

Germany

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
01-07-2025
Processing Time Days
481
Number Of Sites
9
Number Of Participants
78

Sites

Site Name
Universitaetsklinikum Jena KöR
Department Name
Department of Urology
Contact Person Name
Marc-Oliver Grimm
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Department of Urology
Contact Person Name
Steffen Rausch
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
National Center for Tumor Diseases (NCT) Heidelberg
Contact Person Name
Stefanie Zschaebitz
Site Name
Universitaetsklinikum Essen AöR
Department Name
Department of Urology
Contact Person Name
Viktor Grünwald
Contact Person Email
viktor.gruenwald@uk-essen.de
Site Name
Muenchen Klinik gGmbH
Department Name
Department of Oncology and Hematology
Contact Person Name
Stefan Böck
Site Name
Barmherzige Brueder Trier gGmbH
Department Name
Department of Urology
Contact Person Name
Andreas Neisius
Contact Person Email
a.neisius@bbtgruppe.de
Site Name
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Department Name
Studienpraxis Urologie
Contact Person Name
Tilman Todenhoefer
Contact Person Email
todenhoefer@studienurologie.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Department of Oncology with Section Hematology
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com
Site Name
Marien Hospital Herne Universitatsklinikum Der Ruhr-Universitat Bochum
Department Name
Department of Urology
Contact Person Name
Florian Roghmann

Belgium

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
01-07-2025
Processing Time Days
481
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Medicine Oncology
Contact Person Name
Philip Debruyne
Contact Person Email
philip.debruyne@azgroeninge.be
Site Name
Institut Jules Bordet
Department Name
Medicine Oncology
Contact Person Name
Spyridon Sideris

Spain

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
04-07-2025
Processing Time Days
484
Number Of Sites
16
Number Of Participants
121

Sites

Site Name
MD Anderson Cancer Center
Department Name
Medical Oncology
Contact Person Name
Fabio Franco Perez
Contact Person Email
ffranco@fundacionmdanderson.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical Oncology
Contact Person Name
Andres Manuel Cervantes Ruiperez
Contact Person Email
andres.cervantes@uv.es
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Medical Oncology
Contact Person Name
Jose Luis Perez Gracia
Contact Person Email
jlgracia@unav.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Medical Oncology
Contact Person Name
Jose Pablo Maroto Rey
Contact Person Email
jmaroto@santpau.cat
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Medical Oncology
Contact Person Name
Jose Luis Perez Gracia
Contact Person Email
jlgracia@unav.es
Site Name
Hospital Universitario La Paz
Department Name
Medical Oncology
Contact Person Name
Beatriz Castelo Fernandez
Contact Person Email
castelobeatriz@gmail.com
Site Name
Hospital Universitario De Badajoz
Department Name
Medical Oncology
Contact Person Name
Marta González Cordero
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Medical Oncology
Contact Person Name
Alejandro Falcón
Contact Person Email
afalconglez@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Contact Person Name
Juan Martin Liberal
Contact Person Email
jmartinliberal@iconcologia.net
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Medical Oncology
Contact Person Name
Regina Girones
Contact Person Email
girones_reg@gva.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Medical Oncology
Contact Person Name
Almudena García Castaño
Contact Person Email
almudena.garcia@scsalud.es
Site Name
Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
Department Name
Medical Oncology
Contact Person Name
Cristina Suárez Rodríguez
Contact Person Email
csuarez@vhio.net
Site Name
Hospital Clinic De Barcelona
Department Name
Medical Oncology
Contact Person Name
Oscar Reig Torras
Contact Person Email
oreig@clinic.cat
Site Name
Hospital Clinico San Carlos
Department Name
Medical Oncology
Contact Person Name
Javier Puente Vazquez
Contact Person Email
jpuente.hcsc@salud.madrid.org
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Medical Oncology
Contact Person Name
Imanol Martinez Salas
Contact Person Email
imanol.martinez@quironsalud.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Contact Person Name
Pablo Gajate Borau
Contact Person Email
pgajateborau@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
487
Number Of Sites
5
Number Of Participants
42

Sites

Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Oddział Chirurgii Onkologicznej II- Urologia
Contact Person Name
Krzysztof Tupikowski
Contact Person Email
tupikowski.k@dco.com.pl
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Wojewódzkie Centrum Onkologii
Contact Person Name
Joanna Wojcik-Tomaszewska
Contact Person Email
jwojcik@wco.gda.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Chemioterapii
Contact Person Name
Piotr Tomczak
Contact Person Email
md.piotr.tomczak@gmail.com
Site Name
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Department Name
-
Contact Person Name
Cezary Szczylik
Contact Person Email
cezary.szczylik@ecz-otwock.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
-
Contact Person Name
Bogdan Żurawski
Contact Person Email
bzur@wp.pl

Sponsor

Primary sponsor

Full Name
Exelixis Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: 1,13,2,6,7 (various CRO functions listed in sponsorDuties)
Name
Pharmaceutical Product Development LLC
Responsibilities
sponsorDuties code: 4
Name
WCG Clinical Inc.
Responsibilities
sponsorDuties code: 15; value: ECG analysis/ review

Third parties

  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Assaygate Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medqia LLC","duties_or_roles":"sponsorDuties code: 15; value: Medical image analysis/ review","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Alliance Pharma Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Smithers PDS LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Labcorp","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1, 13, 2, 6, 7","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties code: 15; value: ECG analysis/ review","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medqia LLC (alternate listing)","duties_or_roles":"sponsorDuties code: 15; value: Medical image analysis/ review","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
XL092
Active Substance
N-(4-FLUOROPHENYL)-N-(4-((7-METHOXY-6-(METHYLCARBAMOYL)QUINOLIN-4-YL)OXY)PHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Investigational (prodAuthStatus: 1)
Dose Levels
maxDailyDoseAmount: 120.00 mg (as listed)
Maximum Dose
maxTotalDoseAmount: 9999.99 mg (as listed)
Investigational Product Name
Relatlimab + Nivolumab Fixed Dose Combination (FDC)
Active Substance
NIVOLUMAB, RELATLIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Investigational (prodAuthStatus: 1)
Dose Levels
maxDailyDoseAmount: 9999.99 mg (as listed)
Maximum Dose
maxTotalDoseAmount: 12000.00 mg (as listed)
Investigational Product Name
Ipilimumab
Active Substance
IPILIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Investigational (prodAuthStatus: 1)
Dose Levels
maxDailyDoseAmount: 1.00 mg/kg (as listed)
Maximum Dose
maxTotalDoseAmount: 4.00 mg/kg (as listed)
Investigational Product Name
OPDIVO 10 mg/mL concentrate for solution for infusion.
Active Substance
NIVOLUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Marketing authorisation: EU (marketingAuthNumber: EU/1/15/1014/002; prodAuthStatus: 2)
Dose Levels
maxDailyDoseAmount: 480.00 mg (as listed)
Maximum Dose
maxTotalDoseAmount: 12000.00 mg (as listed)
Combination Treatment
Yes

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