A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and clinical activity of GEN1042 in combination with radiotherapy with or without pembrolizumab as a treatment option for patients with metastatic solid tumors

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

Details

• Lead Sponsor: Genmab
• Collaborator: BioNTech SE
• Treatments: Pembrolizumab

Criteria

Key Inclusion Criteria:

• Participants with histologically confirmed non-CNS solid tumor that is metastatic and for whom there is no available standard therapy

• At least 18 years of age

• Signed informed consent prior to any screening procedures

• Measurable disease according to RECIST v 1.1

• Life expectancy of >3 months

• Qualify for palliative radiotherapy as an available option for disease management

• Eastern Cooperative Oncology Group (ECOG) 0-1

• Normal or adequate liver, renal, cardiac and bone marrow function

Key Exclusion Criteria:

• Prior malignancy except for non-melanoma skin cancers and in situ cancers

• Condition contraindicating radiotherapy

• Rapidly progressing disease

• Active, known or suspected autoimmune disease

• History of non-infectious pneumonitis that required steroids or currently has pneumonitis

• Contraindications to the use of pembrolizumab

• Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first treatment

• Received an allogeneic tissue/solid organ transplant

• Active infection requiring systemic therapy

Note: Other protocol defined inclusion/exclusion criteria may apply.