NCT05180474

GEN1047 for Solid Tumors - First in Human (FIH) Trial

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1047 in Subjects With Malignant Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to measure the following in participants with solid tumors who receive GEN1047: * The side effects seen with GEN1047 * What the body does with GEN1047 once it is administered * What GEN1047 does to the body once it is administered * How well GEN1047 works against solid tumors The estimated trial duration for an individual participant is 8 months, consisting of a 28-day screening period, an estimated 3 month treatment period (the duration of treatment may vary for each participant), and an estimated 4 month post-treatment follow-up period (the duration of follow-up may vary for each participant). All participants will receive active drug; no one will be given placebo.

Detailed description

The trial is an open-label, multi-center safety trial of GEN1047. The trial consists of two parts: a dose escalation part ("escalation" - phase 1) and an expansion part ("expansion" - phase 2a). The goal of the dose escalation part is to find out if GEN1047 is safe in participants with specific solid tumors and to find the best dose(s). In the expansion part of the trial up to two doses of GEN1047 will be tested.

Conditions

• Breast Cancer, Breast Neoplasms
• Endometrial Cancer, Endometrial Neoplasm
• Ovarian Cancer, Ovarian Neoplasms
• Squamous Non Small Cell Lung Cancer (NSCLC-SCC)

Interventions

Type	Name	Description
BIOLOGICAL	GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells.	GEN1047 will be administered as an intravenous infusion. The dose-levels will be determined by the starting dose and the escalation steps taken in the trial.

Timeline

• Start date: 2021-12-13
• Primary completion: 2026-03-25
• Completion: 2026-03-25
• First posted: 2022-01-06
• Last updated: 2026-04-13

Locations

36 sites across 9 countries: United States, Belgium, Denmark, France, Italy, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study