NCT06573294

Trial to Assess the Safety and Antitumor Activity of GEN1057 in Malignant Solid Tumors

A First-In-Human, Open-Label, Dose Escalation Trial to Evaluate the Safety and Antitumor Activity of GEN1057 in Subjects With Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to study the antibody GEN1057 when used as a single agent for the treatment of certain types of cancer. Trial details include: * The trial duration for an individual participant will be up to approximately 11 months. * The treatment duration for an individual participant will be up to approximately 4 months (the duration of treatment may vary for each participant) and the follow-up duration for an individual participant will be approximately 6 months. Participation in the trial will require visits to the site. All participants will receive active drug; no one will be given placebo.

Detailed description

The trial is a first-in-human (FIH) open-label, multicenter, multinational safety trial. The dose escalation will evaluate different dose levels by assessing safety, tolerability, and early efficacy signals to determine the expansion dose(s) of GEN1057 as monotherapy, as well as characterizing the pharmacokinetic (PK) profile and immunogenicity in participants with malignant solid tumors who have metastatic or advanced disease.

Conditions

• Advanced Malignant Solid Tumors
• Metastatic Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	GEN1057	Intravenous (IV) infusion
DRUG	Premedication	IV infusion/orally by mouth.

Timeline

• Start date: 2024-08-28
• Primary completion: 2027-06-15
• Completion: 2027-09-21
• First posted: 2024-08-27
• Last updated: 2026-04-13

Locations

5 sites across 3 countries: United States, Japan, Spain

Regulatory

• FDA-regulated drug study