Description:
To evaluate the safety of GEN1042 in patients with malignant solid tumors
To evaluate the safety of GEN1042 in patients with malignant solid tumors
Recruiting
Phase 1/Phase 2
Drug | Synonyms | Arms |
---|---|---|
GEN1042 | Treatment Administered |
The trial is an open-label, multi-center, safety trial of GEN1042. The trial consists of two parts, a dose escalation (phase 1, first-in-human (FIH) and an expansion part (Phase 2a). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.
Name | Type | Description | Interventions |
---|---|---|---|
Treatment Administered | Experimental | GEN1042 will be administered every 21 days |
|
Inclusion Criteria: Dose Escalation: • Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy. Expansion: • Histologically or cytologically confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, or CRC who are not anymore candidates for standard therapy Dose Escalation and Expansion: - Measurable disease according to RECIST 1.1 - Eastern Cooperative Oncology Group (ECOG) 0-1 - Acceptable bone marrow and hematological, liver and renal functions - Acceptable coagulation status Exclusion Criteria: Uncontrolled intercurrent illness, including but not limited to: - Ongoing or active infection treated with intravenous anti-infective therapy less than 2 weeks prior to first dose - Symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia. - Uncontrolled hypertension despite optimal medical management. - Evidence of significant autoimmune disease suggesting risk for immune-related adverse events (irAEs). - History of irAEs that led to treatment discontinuation of prior ICP inhibitor - • History of chronic liver disease or evidence of hepatic cirrhosis. - History of non-infectious pneumonitis that required steroids or currently has pneumonitis. - History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of GEN1042. - Serious, non-healing wound, skin ulcer (of any grade), or bone fracture. - Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or progressive brain metastases or stroke. Prior therapy: - Radiotherapy within 14 days prior to first GEN1042 administration - 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. - History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy - Toxicities from previous anti-cancer therapies that have not resolved
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Dose Limiting Toxicity (DLT) |
Time Frame: | First Cycle (21 days) |
Safety Issue: | |
Description: | Determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) |
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Genmab |
August 16, 2021