GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors

Key Inclusion Criteria:

Monotherapy - Dose Escalation and Dose Expansion Parts

Subjects with non-CNS solid tumors that is metastatic or unresectable and for whom there is no available standard therapy.
Subjects 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

Subjects 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.
Subjects with Stage IV metastatic or recurrent NSCLC with no prior systemic anticancer therapy, no actionable mutation.
Subjects with recurrent or metastatic HNSCC with no prior systemic therapy administered in the recurrent or metastatic setting and tumor demonstrating PD-L1 IHC CPS ≥1.
Subjects 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
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 Exclusion Criteria:

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)

Subject 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
Subject 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.