A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1042 in Subjects With Malignant Solid Tumors
- Study HIC#:2000027214
- Last Updated:07/15/2021
To evaluate the safety of GEN1042 in patients with malignant solid tumors.
- Start Date10/08/2020
- End Date07/01/2022
Trial Purpose and Description
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.
• Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.
• 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
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.
- 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