NCT05435339

A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy

First-in-Human, Open-label, Dose-Escalation Trial With an Expansion Cohort to Evaluate the Safety of GEN1053 as Monotherapy in Subjects With Malignant Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The drug that will be investigated in the study is GEN1053. GEN1053 is an antibody designed to (re)activate and increase antitumor immunity. Since this is the first study of GEN1053 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN1053 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1053. GEN1053 will be studied in a broad group of cancer patients, having different kinds of solid tumors. All participants will get GEN1053. The study consists of two parts: Part 1 tests increasing doses of GEN1053 ("escalation"), followed by Part 2 which tests the recommended phase 2 dose GEN1053 dose from Part 1 ("expansion").

Detailed description

The trial is a First in Human open-label, multicenter, multinational safety trial in participants with non-central nervous system (non-CNS) metastatic or advanced malignant solid tumors for whom there is no available standard therapy likely to confer clinical benefit, evaluating the safety, tolerability, preliminary antitumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of GEN1053. The trial will be conducted as follows: * The Dose Escalation part (Part 1) will explore the safety of escalating doses of GEN1053 as monotherapy (phase 1) * The Expansion part (Part 2) is planned to provide additional safety and initial antitumor activity information of the Recommended Phase 2 dose (RP2D) for GEN1053 monotherapy in selected tumor indications, as well as more detailed data related to the mode of action (MoA).

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
BIOLOGICAL	GEN1053	GEN1053 will be administered as an intravenous (IV) infusion every 3rd week. The dose levels will be determined by the starting dose and the escalation steps taken in the trial.

Timeline

• Start date: 2022-10-04
• Primary completion: 2024-05-24
• Completion: 2024-05-24
• First posted: 2022-06-28
• Last updated: 2025-04-22
• Results posted: 2025-04-22

Locations

5 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study