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

NCT05180474 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Genmab

    lead INDUSTRY

Principal Investigators

  • Study Official · Genmab

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-13
Primary Completion
2026-03-25
Completion
2026-03-25
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • France
  • Italy
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05180474 on ClinicalTrials.gov