Clinical trial • Phase II • Oncology
TARLATAMAB for Small cell lung cancer | Relapsed/refractory small cell lung cancer
Phase II trial of TARLATAMAB for Small cell lung cancer | Relapsed/refractory small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Small cell lung cancer | Relapsed/refractory small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- Other antibody|Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 08-08-2024
- First CTIS Authorization Date
- 09-10-2024
Trial design
Randomised, open-label, none/not specified-controlled, adaptive Phase II trial in Austria, France, Denmark and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, Part 1 includes randomisation to two dose levels with an interim analysis when 30 subjects per dose level have had opportunity to confirm objective response; based on safety/efficacy one investigational arm may be stopped and a selected target dose chosen for expansion (Part 2); enrollment continues during interim assessment.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 180
Eligibility
Recruits 180 Vulnerable populations not selected (isVulnerablePopulationSelected=false). Consent requirement: "101 Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures." Subjects are adults (>=18 years) per eligibility; assent mention present in consent wording..
- Vulnerable Population
- Vulnerable populations not selected (isVulnerablePopulationSelected=false). Consent requirement: "101 Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures." Subjects are adults (>=18 years) per eligibility; assent mention present in consent wording.
Inclusion criteria
- {"criterion_text":"- 101 Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures."}
- {"criterion_text":"- 110 Adequate organ function, defined as follows: hematological function: - absolute neutrophil count >= 1 x 10^9/L - platelet count >= 100 x 10^9/L - hemoglobin > 9 g/dL (90 g/L) coagulation function: - prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) <= 1.5 x institutional upper limit of normal (ULN). Subjects on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enroll after discussion with the medical monitor. renal function: - estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation > 30 mL/min/1.73 m2 hepatic function: - aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) < 3 X ULN (or < 5 X ULN for subjects with liver involvement) - total bilirubin < 1.5 X ULN (or < 2 X ULN for subjects with liver metastases). pulmonary function: - no clinically significant pleural effusion - baseline oxygen saturation > 90% on room air cardiac function: - cardiac ejection fraction >= 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings"}
- {"criterion_text":"- 102 Male and female subjects >= 18 years of age (or legal adult age within country) at the time of signing the informed consent."}
- {"criterion_text":"- 103 Histologically or cytologically confirmed relapsed/refractory SCLC"}
- {"criterion_text":"- 104 Subjects who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy Note: (1) re-treatment with a platinum-based regimen is considered a second line of therapy; (2) platinum-based regimen followed by checkpoint inhibitor/anti-programmed death ligand 1 (PD-L1) as maintenance therapy is considered 1 line of therapy; (3) in countries where standard of care first line systemic treatment includes platinum containing chemotherapy in combination with PD-L1 inhibitor, it is required that patients have failed PD-L1 inhibitor as part of their first line systemic treatment or are ineligible to receive PD-L1 inhibitor therapy."}
- {"criterion_text":"- 105 Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded [FFPE] sample) or willing to undergo pretreatment tumor biopsy. Subjects who do not have archived tumor tissue available and are unable to undergo a pretreatment tumor biopsy due to extenuating circumstances (eg, cannot be performed safely or inaccessible, as determined by the investigator) may be allowed to enroll without a tumor biopsy upon agreement between the investigator and Amgen medical monitor."}
- {"criterion_text":"- 106 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1."}
- {"criterion_text":"- 107 Minimum life expectancy of 12 weeks."}
- {"criterion_text":"- 108 Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of Tarlatamab."}
- {"criterion_text":"- 109 Subjects with treated brain metastases are eligible provided they meet the following criteria: - Definitive therapy was completed at least 2 weeks prior to the first dose of Tarlatamab. - There is no evidence of radiographic central nervous system (CNS) progression following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor. - Any CNS disease is asymptomatic for at least 7 days (unless symptoms are deemed irreversible by the investigator), the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the subject is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days."}
Exclusion criteria
- {"criterion_text":"- 201 Untreated or symptomatic brain metastases and leptomeningeal disease."}
- {"criterion_text":"- 204 Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible(defined as having been present and stable for > 21 days) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen."}
- {"criterion_text":"- 205 History of other malignancy within the past 2 years, with the following exceptions: - malignancy treated with curative intent and with no known active disease present for >= 2 years before enrollment and felt to be at low risk for recurrence by the treating physician. - adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. - adequately treated cervical carcinoma in situ without evidence of disease. - adequately treated breast ductal carcinoma in situ without evidence of disease. - prostatic intraepithelial neoplasia without evidence of prostate cancer. - adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ."}
- {"criterion_text":"- 206 Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of Tarlatamab (Section 11.9)."}
- {"criterion_text":"- 207 History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of Tarlatamab."}
- {"criterion_text":"- 208 Subject with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of Tarlatamab. NOTE: Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. Subjects requiring oral antibiotics who have been afebrile > 24 hours, have no leukocytosis and have no clinical signs of infection are eligible. Subjects who meet these criteria and who were previously on IV antimicrobials should have been off IV antimicrobials for > 48 hours."}
- {"criterion_text":"- 209 Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or peritoneal/pericardial catheter). NOTE: A pleural catheter or dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted."}
- {"criterion_text":"- Please refer to protocol for exclusion criteria 217 to 238."}
- {"criterion_text":"- 210 History of hypophysitis or pituitary dysfunction."}
- {"criterion_text":"- 211 Exclusion of hepatitis infection based on the following results and/or criteria: - Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B). - Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B. - Positive hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C"}
- {"criterion_text":"- 212 Major surgery within 28 days of first dose Tarlatamab."}
- {"criterion_text":"- 214 Subject received prior therapy with Tarlatamab."}
- {"criterion_text":"- 215 Prior anti-cancer therapy within 28 days prior to first dose of Tarlatamab. Exceptions: - Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to grade <=1. - Prior palliative radiotherapy must have been completed at least 7 days before the first dose of Tarlatamab."}
- {"criterion_text":"- 216 Has a diagnosis of immunodeficiency (e.g. positive/non-negative test for human immunodeficiency virus) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of Tarlatamab."}
- {"criterion_text":"- 202 Has evidence of interstitial lung disease or active, non-infectious pneumonitis."}
- {"criterion_text":"- 203 Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Part 1 only - objective response (OR) (complete response [CR] and partial response [PR]) •incidence of treatment-emergent adverse events (TEAEs) •serum concentrations of Tarlatamab","definition_or_measurement_approach":"Objective response (OR: CR and PR) assessed per RECIST 1.1 (Part 1 by investigator); incidence of TEAEs assessed using CTCAE; serum concentrations measured by PK assays (serum PK)."}
- {"endpoint_text":"- Part 1 and 2 - OR (CR and PR)","definition_or_measurement_approach":"Objective response (CR and PR) assessed per RECIST 1.1 by blinded independent central review (BICR) (as indicated in objectives)."}
- {"endpoint_text":"- Part 3 - Incidence of TEAEs","definition_or_measurement_approach":"Incidence of treatment-emergent adverse events collected and reported per CTCAE and study safety monitoring procedures."}
Secondary endpoints
- {"endpoint_text":"- duration of response (DOR)","definition_or_measurement_approach":"DOR = time from first documented response (CR or PR) to progression or death; assessed per RECIST 1.1."}
- {"endpoint_text":"- disease control (DC)","definition_or_measurement_approach":"Disease control assessed per RECIST 1.1 (includes CR, PR, and stable disease) as defined in study."}
- {"endpoint_text":"- duration of DC","definition_or_measurement_approach":"Duration of disease control measured from first documentation of disease control until progression or death."}
- {"endpoint_text":"- progression-free survival (PFS)","definition_or_measurement_approach":"PFS = time from first dose to documented progression per RECIST 1.1 or death."}
- {"endpoint_text":"- DOR","definition_or_measurement_approach":"Same as duration of response (see above)."}
- {"endpoint_text":"- overall survival (OS)","definition_or_measurement_approach":"OS = time from first dose to death from any cause."}
- {"endpoint_text":"- incidence of TEAEs","definition_or_measurement_approach":"Incidence of treatment-emergent adverse events collected and reported per CTCAE."}
- {"endpoint_text":"- serum concentrations of Tarlatamab","definition_or_measurement_approach":"Serum concentrations measured by validated PK assays at scheduled timepoints."}
- {"endpoint_text":"- incidence of anti-Tarlatamab antibody formation","definition_or_measurement_approach":"Immunogenicity assessed by detection of anti-drug antibodies using validated assays; incidence recorded."}
Recruitment
- Planned Sample Size
- 180
- Recruitment Window Months
- 66
- Consent Approach
- Informed consent is required from each subject prior to any study-specific activities: "101 Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures." Multiple subject information and informed consent form documents are provided (country/language-specific ICFs and study information sheets listed among study documents), with country-specific versions available per participating Member State.
Geography
- Total Number Of Sites
- 23
- Total Number Of Participants
- 113
Austria
- Earliest CTIS Part Ii Submission Date
- 08-08-2024
- Latest Decision Or Authorization Date
- 01-12-2025
- Processing Time Days
- 480
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Universitaetsklinikum Krems
- Department Name
- Klinische Abteilung fuer Pneumologie
- Principal Investigator Name
- Sabin Handzhiev
- Principal Investigator Email
- Sabin.Handzhiev@krems.lknoe.at
- Contact Person Name
- Sabin Handzhiev
- Contact Person Email
- Sabin.Handzhiev@krems.lknoe.at
France
- Earliest CTIS Part Ii Submission Date
- 08-08-2024
- Latest Decision Or Authorization Date
- 01-12-2025
- Processing Time Days
- 480
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Service Pneumologie
- Principal Investigator Name
- Laurent GREILLIER
- Principal Investigator Email
- laurent.greillier@ap-hm.fr
- Contact Person Name
- Laurent GREILLIER
- Contact Person Email
- laurent.greillier@ap-hm.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service Pneumologie
- Principal Investigator Name
- Sebastien Couraud
- Principal Investigator Email
- sebastien.couraud@chu-lyon.fr
- Contact Person Name
- Sebastien Couraud
- Contact Person Email
- sebastien.couraud@chu-lyon.fr
- Site Name
- Institut Curie
- Department Name
- Service Pneumologie
- Principal Investigator Name
- Pauline Du Rusquec
- Principal Investigator Email
- pauline.durusquec@curie.fr
- Contact Person Name
- Pauline Du Rusquec
- Contact Person Email
- pauline.durusquec@curie.fr
Denmark
- Earliest CTIS Part Ii Submission Date
- 08-08-2024
- Latest Decision Or Authorization Date
- 28-07-2025
- Processing Time Days
- 354
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Oncology
- Principal Investigator Name
- Seppo Langer
- Principal Investigator Email
- Seppo.Langer@regionh.dk
- Contact Person Name
- Seppo Langer
- Contact Person Email
- Seppo.Langer@regionh.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 08-08-2024
- Latest Decision Or Authorization Date
- 28-11-2025
- Processing Time Days
- 477
- Number Of Sites
- 8
- Number Of Participants
- 49
Sites
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Servicio de Oncología
- Principal Investigator Name
- María Vanesa Gutierrez Calderón
- Principal Investigator Email
- vanesa_gutierrez78@hotmail.com
- Contact Person Name
- María Vanesa Gutierrez Calderón
- Contact Person Email
- vanesa_gutierrez78@hotmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Oncología
- Principal Investigator Name
- Luis Paz-Ares Rodriguez
- Principal Investigator Email
- lpazaresr@seom.org
- Contact Person Name
- Luis Paz-Ares Rodriguez
- Contact Person Email
- lpazaresr@seom.org
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Servicio de Oncología
- Principal Investigator Name
- Oscar Jose Juan Vidal
- Principal Investigator Email
- Juan_osc@gva.es
- Contact Person Name
- Oscar Jose Juan Vidal
- Contact Person Email
- Juan_osc@gva.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Servicio de Oncología
- Principal Investigator Name
- Noemi Reguart Aransay
- Principal Investigator Email
- nreguart@clinic.cat
- Contact Person Name
- Noemi Reguart Aransay
- Contact Person Email
- nreguart@clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Oncología
- Principal Investigator Name
- Enriqueta Felip Font
- Principal Investigator Email
- efelip@vhio.net
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Servicio de Oncología
- Principal Investigator Name
- Mariano Provencio Pulla
- Principal Investigator Email
- mprovencio.ensayosclinicos@gmail.com
- Contact Person Name
- Mariano Provencio Pulla
- Contact Person Email
- mprovencio.ensayosclinicos@gmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Servicio de Oncología
- Principal Investigator Name
- Margarita Majem Tarruella
- Principal Investigator Email
- mmajem@santpau.cat
- Contact Person Name
- Margarita Majem Tarruella
- Contact Person Email
- mmajem@santpau.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe (duplicate listing?)
- Department Name
- Servicio de Oncología
Greece
- Earliest CTIS Part Ii Submission Date
- 08-08-2024
- Latest Decision Or Authorization Date
- 27-11-2025
- Processing Time Days
- 476
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- Site Name
- Euromedica General Clinic Of Thessaloniki
- Department Name
- B’ Oncology Unit
- Principal Investigator Name
- Georgios Fountzilas
- Principal Investigator Email
- fountzil@auth.gr
- Contact Person Name
- Georgios Fountzilas
- Contact Person Email
- fountzil@auth.gr
- Site Name
- Henry Dunant Hospital Center
- Department Name
- 4th Department of Oncology
- Principal Investigator Name
- Ioannis Mountzios
- Principal Investigator Email
- gmountzios@gmail.com
- Contact Person Name
- Ioannis Mountzios
- Contact Person Email
- gmountzios@gmail.com
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Medical Oncology Unit
- Principal Investigator Name
- Sofia Agelaki
- Principal Investigator Email
- agelaki@med.uoc.gr
- Contact Person Name
- Sofia Agelaki
- Contact Person Email
- agelaki@med.uoc.gr
Poland
- Earliest CTIS Part Ii Submission Date
- 08-08-2024
- Latest Decision Or Authorization Date
- 30-11-2025
- Processing Time Days
- 479
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Principal Investigator Name
- Rafał Dziadziuszko
- Principal Investigator Email
- obkwf@uck.gda.pl
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- obkwf@uck.gda.pl
Belgium
- Earliest CTIS Part Ii Submission Date
- 08-08-2024
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 475
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- UZ Leuven
- Department Name
- Department of Pneumology
- Principal Investigator Name
- Els Wauters
- Principal Investigator Email
- els.wauters@uzleuven.be
- Contact Person Name
- Els Wauters
- Contact Person Email
- els.wauters@uzleuven.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Respiratory Medicine
- Principal Investigator Name
- Karim Vermaelen
- Principal Investigator Email
- karim.vermaelen@Ugent.be
- Contact Person Name
- Karim Vermaelen
- Contact Person Email
- karim.vermaelen@Ugent.be
Italy
- Earliest CTIS Part Ii Submission Date
- 08-08-2024
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 475
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Oncology
- Principal Investigator Name
- Lorenza Landi
- Principal Investigator Email
- lorenza.landi@ifo.it
- Contact Person Name
- Lorenza Landi
- Contact Person Email
- lorenza.landi@ifo.it
- Site Name
- Azienda Ospedaliero Universitaria Parma
- Department Name
- Oncology
- Principal Investigator Name
- Marcello Tiseo
- Principal Investigator Email
- mtiseo@ao.pr.it
- Contact Person Name
- Marcello Tiseo
- Contact Person Email
- mtiseo@ao.pr.it
Germany
- Earliest CTIS Part Ii Submission Date
- 08-08-2024
- Latest Decision Or Authorization Date
- 27-11-2025
- Processing Time Days
- 476
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- University Hospital Cologne AöR
- Department Name
- Clinic for Internal Medicine
- Principal Investigator Name
- Juergen Wolf
- Principal Investigator Email
- lungenkrebs@uk-koeln.de
- Contact Person Name
- Juergen Wolf
- Contact Person Email
- lungenkrebs@uk-koeln.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Comprehensive Cancer Center Mainfranken (CCCM)
- Principal Investigator Name
- Horst-Dieter Hummel
- Principal Investigator Email
- isz_koordination@ukw.de
- Contact Person Name
- Horst-Dieter Hummel
- Contact Person Email
- isz_koordination@ukw.de
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Iqvia Inc.
- Responsibilities
- ECG collect and hold; overall clinical trial support (contact eu_clinical_trials_information@iqvia.com).
- Name
- Excelya Greece CRO Single Member S.A.
- Responsibilities
- Local CRO responsibilities (contact info-greece@excelya.com).
Third parties
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"ECG collect and hold; sponsor duties codes present (code 1, code 15). Contact email: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Reify Health Inc.","duties_or_roles":"Facilitate collection of pre-screen data for the study","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"MSD 10 Plex Cytokine Panel (PIP Panel) Tact & Treg (CD357) Panel (A344) T Cell Exhaustion TIGIT Pane; sponsor duties code 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Tumor Tissue, PBMC, Biomarker, ctDNA, PK, and PG sample collection and processing for transfer to external testing labs.","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"Logistics/sample handling; sponsor duties code 3","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Kayentis","duties_or_roles":"Collection of Patient Reported Outcome assessments; sponsor duties codes 15 and 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"Sponsor duties code 1 (local CRO functions)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"Sponsor duties code 4 (testing/analysis)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"Tumor/DLL3 and gene expression slide preparation; specified slide requirements","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Central equipment supplier","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Laboratory sample storage","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Amgen Research (Munich) GmbH","duties_or_roles":"Laboratory / scientific support; sponsor duties code 4","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Syngene International Limited","duties_or_roles":"Laboratory/analysis support; sponsor duties code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Radmd LLC","duties_or_roles":"Medical image analysis","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- Tarlatamab
- Active Substance
- TARLATAMAB
- Modality
- Other antibody
- Routes Of Administration
- Intravenous use
- Route
- Intravenous
- Authorisation Status
- prodAuthStatus:1
- Orphan Designation
- Yes
- Starting Dose
- 10 mg (lowest randomized dose listed)
- Dose Levels
- 10 mg; 100 mg
- Maximum Dose
- 100 mg (max daily dose amount)
- Dose Escalation Increase
- Initial dose 10 mg; following dose 100 mg
- Investigational Product Name
- SILTUXIMAB
- Active Substance
- SILTUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous use
- Route
- Intravenous
- Authorisation Status
- prodAuthStatus:2
- Maximum Dose
- 11 mg/kg (max daily dose amount)
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