NCT05491317

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose is to assess the safety and clinical activity of GEN1042 in combination with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a treatment option for participants with metastatic solid tumors.

Detailed description

The study will be conducted in two parts: Part 1 (dose-finding) and Part 2 (randomization). Part 1 will evaluate the safety of immunoradiotherapy combinations and establish the dose(s) to be evaluated in Part 2. Part 2 will evaluate the anti-tumor activity of immunoradiotherapy combinations at the established dose(s) from Part 1. Participants in both parts are treated with one of the following combinations: * Radiotherapy + GEN1042 * Radiotherapy + GEN1042 + Pembrolizumab While participants in Part 1 are assigned sequentially (GEN1042 without pembrolizumab is investigated first), participants in Part 2 are randomized 1:1 in the two treatment arms.

Conditions

• Non-CNS Tumor

Interventions

Type	Name	Description
BIOLOGICAL	GEN1042	Intravenous
DRUG	Pembrolizumab	Intravenous
RADIATION	Radiotherapy	Radiotherapy

Timeline

• Start date: 2023-03-08
• Primary completion: 2025-08-11
• Completion: 2025-08-11
• First posted: 2022-08-08
• Last updated: 2026-02-19

Locations

2 sites across 1 country: France

Regulatory

• FDA-regulated drug study