NCT06771921

A First-in-Human Trial of Safety and Efficacy of GEN1078 in Participants With Solid Tumors

First-in-Human, Open-Label, Dose-Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of GEN1078 in Subjects With Malignant Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (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 cancers who receive GEN1078. * The side effects seen with GEN1078 * What the body does with GEN1078 once it is administered * What GEN1078 does to the body once it is administered * How well GEN1078 works against advanced solid tumors Trial details include: * The estimated trial duration is 8 months for an individual participant (the trial duration may vary for each participant). * The treatment duration will be an estimated 3-month treatment period (the duration of treatment may vary for each participant). * The visit frequency will be daily or visits every few days for the first few months. All participants will receive active drug; no one will be given placebo.

Conditions

• Malignant Solid Tumor

Interventions

Type	Name	Description
DRUG	GEN1078	Specified dose on specified days.

Timeline

• Start date: 2025-01-29
• Primary completion: 2025-06-11
• Completion: 2025-06-11
• First posted: 2025-01-13
• Last updated: 2026-01-30

Locations

6 sites across 2 countries: Denmark, Spain