Genmab-BioNTech trial of GEN1042 combos posts results after early end for lack of efficacy

This week's update covers a single terminated trial from Genmab, sponsored with BioNTech SE as collaborator, with new dose limiting toxicity data now posted.

• The trial, "A Phase 1 Dose Finding and Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Clinical Activity of Immunoradiotherapy Combinations as a Treatment Option in Subjects With Metastatic Solid Tumors" (NCT05491317), tested GEN1042 plus radiotherapy, with or without pembrolizumab, in participants with metastatic non-CNS solid tumors. The study was marked terminated, with the sponsor stating that after reviewing all available data from Part 1 of the trial, the Sponsor has decided not to proceed to Part 2 (randomized Phase 2) of the trial due to lack of efficacy. Enrollment reached 13 participants (actual)¹, and primary completion was recorded as 2025-08-11 (actual).
• Newly posted safety results from Part 1 show no dose limiting toxicities in the first two SBRT dose cohorts tested with GEN1042: Part 1 Cohort 1: 27Gy Stereotactic Body Radiotherapy (SBRT) + GEN1042: 0.¹