NCT03917381

GEN1046 Safety Trial in Patients With Malignant Solid Tumors

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 429 (actual)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this trial is to learn about the antibody acasunlimab (an antibody also known as GEN1046) when it is used alone and when it is used together with standard of care treatment (docetaxel) or another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of patients with certain types of cancer. All subjects will receive active drug; no one will receive placebo. This trial has 2 parts. The purpose of the first part is to find out if acasunlimab at various doses is safe and to find out the best doses of acasunlimab to use. The purpose of the second part is to give acasunlimab to more subjects to see how well the doses of acasunlimab selected in the first part work against cancer when given alone and how well they work when given with pembrolizumab with or without chemotherapy. Trial details include: * The average trial duration for an individual subject will be about 74 weeks. * The average treatment duration for an individual subject will be about 21 weeks. * The visit frequency will be weekly at first and lessening over time until visits are only once every 3 weeks.

Detailed description

The trial is an open-label, multi-center safety trial of acasunlimab (GEN1046). The trial consists of 2 consecutive parts: a first-in-human (FIH) dose escalation (phase 1) and an expansion (phase 2a). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	Acasunlimab	Acasunlimab will be administered intravenously once every 21 days (in selected expansion cohorts acasunlimab will be administered intravenously once every 21 days for the first 2 cycles, and every 42 days in subsequent cycles).
BIOLOGICAL	Acasunlimab in combination with docetaxel (in a single expansion cohort)	Acasunlimab and docetaxel will be administered intravenously once every 21 days.
BIOLOGICAL	Acasunlimab in combination with pembrolizumab (in a separate expansion cohort)	Acasunlimab and pembrolizumab will be administered intravenously once every 21 days or every 42 days, respectively.
BIOLOGICAL	Acasunlimab in combination with pembrolizumab and standard chemotherapy (in separate expansion cohorts)	Acasunlimab and pembrolizumab and standard chemotherapy will be administered intravenously once every 21 days for 4 cycles, followed by treatment with acasunlimab and pembrolizumab once every 21 days.

Timeline

• Start date: 2019-05-14
• Primary completion: 2025-04-01
• Completion: 2026-08-31
• First posted: 2019-04-17
• Last updated: 2026-04-06

Locations

57 sites across 10 countries: United States, Czechia, Georgia, Hungary, Israel, Italy, Poland, Spain, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study