Study on GEN1042 Safety and Anti-Tumor Effects in Patients with Advanced Solid Tumors

Inclusion Criteria

• For Monotherapy: Patients with solid tumors that are not in the central nervous system, have spread or cannot be removed by surgery, and have no other standard treatment options.
• Patients with advanced or metastatic melanoma, non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) that has returned or not responded to treatment, with no other standard treatment options.
• For Combination Therapy: Patients with Stage III or IV melanoma that cannot be removed by surgery and have not received prior systemic treatment for the disease. Excludes primary ocular or mucosal melanoma.
• Patients with Stage IV metastatic or recurrent NSCLC with no prior systemic treatment and no actionable mutation.
• Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with no prior systemic treatment in the recurrent or metastatic setting.
• Patients with confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) with no previous treatment for metastatic disease.
• Must be 18 years or older or the legal age of consent in the trial location.
• Must have measurable disease according to specific medical criteria.
• Must have a performance status indicating full activity or some restriction in strenuous activities.
• Must have normal or adequate liver, kidney, heart, and bone marrow function.

Exclusion Criteria

• For Monotherapy: Patients who have received anti-cancer treatment within 21 days or after at least 5 half-lives of the drug before starting GEN1042.
• Patients who have had radiotherapy within 14 days before starting GEN1042.
• Patients with unresolved side effects from previous cancer treatments.
• For Combination Therapy: Patients who have received prior systemic chemotherapy, biological therapy, or major surgery within 3 weeks or at least 5 half-lives of the drug before starting the trial treatment.
• Patients who have had radiotherapy within 14 days of starting the trial treatment or lung radiation therapy of more than 30 Gy within 6 months of starting the trial treatment.
• General: Patients with active, known, or suspected autoimmune diseases.
• Patients with a history of non-infectious lung inflammation requiring steroids or current lung inflammation.
• Patients with a history of severe allergic reactions to monoclonal antibody therapy.
• Patients requiring systemic treatment with corticosteroids (more than 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of starting treatment.

Note: Additional criteria may apply as defined in the study protocol.