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

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumors

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genmab
• Collaborator: BioNTech SE
• Treatments: Carboplatin; Gemcitabine; Paclitaxel; Pembrolizumab

Criteria

Inclusion Criteria:

Phase 1a:

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

Phase 2a:

• 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

Phase 1b/Phase 2:

• 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 and tumor demonstrating PD-L1 expression in ≥1% of tumor cells (TPS ≥1%).

• 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):

Dose Escalation and Expansion:

• 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

Exclusion Criteria:

Phase 1a/Phase 2a

• 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

Phase 1b/Phase 2

• 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.