Informations générales (source: ClinicalTrials.gov)
A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors
Interventional
Phase 1/Phase 2
Genmab (Voir sur ClinicalTrials)
septembre 2019
août 2026
08 août 2025
The goal of this trial is to learn about the antibody GEN1042 when it is used alone and
when it is used together with another antibody cancer drug, pembrolizumab (with or
without chemotherapy), for treatment of participants with certain types of cancer.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline EVEN | 01/07/2024 08:54:52 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre hospitalier Universitaire de Bordeaux - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Gustave Roussy - Villejuif - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
Monotherapy - Dose Escalation and Dose Expansion Parts
- Participants with non-CNS solid tumors that is metastatic or unresectable and for
whom there is no available standard therapy.
- Participants with a confirmed diagnosis of relapsed or refractory, advanced and/or
metastatic melanoma, NSCLC, or CRC and for whom there is no available standard
therapy
Combination Therapy - Dose Expansion Part
- Participants with unresectable Stage III or Stage IV melanoma with no prior systemic
anticancer therapy for unresectable or metastatic disease. Primary ocular or mucosal
melanoma is excluded.
- Participants with Stage IV metastatic or recurrent NSCLC with no prior systemic
anticancer therapy, no actionable mutation.
- Participants with recurrent or metastatic HNSCC with no prior systemic therapy
administered in the recurrent or metastatic setting.
- Participants with confirmed metastatic PDAC with no previous radiotherapy, surgery,
chemotherapy, or investigational therapy for the treatment of metastatic disease.
General (all phases):
- Must be age ≥ 18 years of age on the day of signing informed consent, or the legal
age of consent in the jurisdiction in which the trial is taking place.
- Measurable disease according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Normal or adequate liver, renal, cardiac and bone marrow function
Key
Monotherapy - Dose Escalation and Dose Expansion Parts
- Participants with non-CNS solid tumors that is metastatic or unresectable and for
whom there is no available standard therapy.
- Participants with a confirmed diagnosis of relapsed or refractory, advanced and/or
metastatic melanoma, NSCLC, or CRC and for whom there is no available standard
therapy
Combination Therapy - Dose Expansion Part
- Participants with unresectable Stage III or Stage IV melanoma with no prior systemic
anticancer therapy for unresectable or metastatic disease. Primary ocular or mucosal
melanoma is excluded.
- Participants with Stage IV metastatic or recurrent NSCLC with no prior systemic
anticancer therapy, no actionable mutation.
- Participants with recurrent or metastatic HNSCC with no prior systemic therapy
administered in the recurrent or metastatic setting.
- Participants with confirmed metastatic PDAC with no previous radiotherapy, surgery,
chemotherapy, or investigational therapy for the treatment of metastatic disease.
General (all phases):
- Must be age ≥ 18 years of age on the day of signing informed consent, or the legal
age of consent in the jurisdiction in which the trial is taking place.
- Measurable disease according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Normal or adequate liver, renal, cardiac and bone marrow function
Key
Monotherapy - Dose Escalation and Dose Expansion Parts
- Treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives
of the drug, whichever is shorter), prior to GEN1042 administration
- Radiotherapy within 14 days prior to first GEN1042 administration
- Toxicities from previous anti-cancer therapies that have not resolved
Combination Therapy - Dose Expansion Part
- Has received prior systemic cytotoxic chemotherapy, biological therapy, OR major
surgery within 3 weeks or at least 5 half-lives of the drug (whichever is shorter)
of the first dose of trial treatment.
- Radiotherapy within 14 days of start of trial treatment or received lung radiation
therapy of > 30 Gy within 6 months of the first dose of trial treatment.
General (all phases)
- Participants has an active, known, or suspected autoimmune disease.
- History of non-infectious pneumonitis that required steroids or currently has
pneumonitis.
- History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy
- Participants with a condition requiring systemic treatment with either
corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive
medications within 14 days of first treatment.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.