A Phase 1 Trial of GEN1119 in Participants With Solid Tumors

This is a first-in-human (FIH), Phase 1 open-label, multicenter, multinational trial in participants with certain types of solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of GEN1119.

Key Inclusion Criteria:

• Have histologically or cytologically confirmed diagnosis of protocol-specified solid tumours.
• Have progressed on standard of care (SoC) therapy applicable for the tumor type, or for whom there is no available SoC therapy likely to provide clinical benefit, and for whom experimental therapy with GEN1119 may be a suitable option in the opinion of the investigator.
• Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Have acceptable laboratory test results before GEN1119 administration per protocol

Key Exclusion Criteria:

• Prior treatment with certain protocol-defined therapy.
• Prior treatment with T-cell engagers, chimeric antigen receptor T-cell (CAR-T-cell) therapies, other protocol defined therapies, or other therapeutic moieties targeting certain protocol-defined molecules.
• Treatment with an anticancer agent within 4 weeks or within 5 half lives of the drug, whichever is shorter, but not within 2 weeks before Cycle 1 Day 1 (C1D1).
• Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or lower, except for anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy, which must have recovered to ≤ Grade 2. There is no limitation for alopecia from previous therapies.
• Participant should not have active Hepatitis B infection. Participants with prior infections or chronic infections are allowed if monitored or treated as per local SOC and are negative for hepatitis B virus (HBV) DNA measured viral load.
• Hepatitis C virus (HCV): Known active HCV infection (defined as positive for HCV ribonucleic acid [RNA] [qualitative]).

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.