NCT05586321

Study of Safety and Antitumor Activity of GEN1056 in Participants With Advanced Solid Tumors

A First-in-Human, Open-label, Dose-finding Trial to Evaluate the Safety and Antitumor Activity of GEN1056 in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this first-in-human study of GEN1056, is to evaluate safety. In addition, the study will determine the recommended dose and frequency for subsequent clinical studies and will assess the preliminary anti-tumor activity of GEN1056. GEN1056 will be studied in patients with advanced or metastatic solid cancer, for whom standard of care (SOC) therapy is not an option. All participants will get GEN1056.

Detailed description

The trial is a first-in-human open-label, dose-finding, multinational safety trial, in participants with advanced or metastatic solid (non central nervous system \[CNS\]) tumors that have exhausted SOC therapy or are not candidates for SOC therapy, evaluating the safety, tolerability, preliminary antitumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of GEN1056. The trial will be conducted as follows: * The Dose Escalation part (Part 1) will explore the safety of escalating doses of GEN1056 * The Dose schedule optimization part (Part 2) will explore further safety and tolerability in an alternate schedule of a dose based on data outcome available from Part 1.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
BIOLOGICAL	GEN1056	GEN1056 will be administered as an intravenous (IV) infusion. The dose levels will be determined by the starting dose and the escalation steps taken in the trial in Part 1. In Part 2, the dose and schedule will be decided based on data outcome from Part 1.

Timeline

• Start date: 2022-10-24
• Primary completion: 2025-10-23
• Completion: 2025-10-23
• First posted: 2022-10-19
• Last updated: 2025-11-24

Locations

7 sites across 3 countries: Georgia, Moldova, Spain