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GEN1046 Safety Trial in Patients With Malignant Solid Tumors

NCT03917381 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 429

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

Interventions

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.

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
2019-05-14
Primary Completion
2025-04-01
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Georgia
  • Hungary
  • Israel
  • Italy
  • Poland
  • Spain
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

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 NCT03917381 on ClinicalTrials.gov