GEN1046 Safety Trial in Patients With Malignant Solid Tumors

Conditions

• Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Acasunlimab — BIOLOGICAL
  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).
• Acasunlimab in combination with docetaxel (in a single expansion cohort) — BIOLOGICAL
  Acasunlimab and docetaxel will be administered intravenously once every 21 days.
• Acasunlimab in combination with pembrolizumab (in a separate expansion cohort) — BIOLOGICAL
  Acasunlimab and pembrolizumab will be administered intravenously once every 21 days or every 42 days, respectively.
• Acasunlimab in combination with pembrolizumab and standard chemotherapy (in separate expansion cohorts) — BIOLOGICAL
  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.

Study Details

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.

Key Dates

First listed

Apr 17, 2019

Start date

May 14, 2019

Status verified

Jul 2026

Primary completion

Apr 1, 2025

Completion

Aug 31, 2026

Study Design

Enrollment

429 participants (actual)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation
  Acasunlimab will be administered as monotherapy.
• Experimental: Expansion
  Acasunlimab will be administered as monotherapy or in combination with either docetaxel, pembrolizumab, or pembrolizumab + standard chemotherapy in separate expansion cohorts.

Primary Outcome Measure

Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLT) [ Time Frame: During first cycle (21 days) ]

Locations (14)

Related coverage on Hipa.ai

• Pembrolizumab trial posts safety data in solid tumors
  Pembrolizumab · Aug 4, 2026 · ClinicalTrials.gov

Find similar trials in Phoenix, AZ

Related Studies

• A Study Using White Blood Cells From Healthy Donors To Treat Solid Cancers
  PHASE1/PHASE2 · Enrolling By Invitation · Dipnarine Maharaj · Boynton Beach, Florida
• CIBMTR Research Database
  Recruiting · Center for International Blood and Marrow Transplant Research · Minneapolis, Minnesota
• Genomic Profiling in Cancer Patients
  Recruiting · Memorial Sloan Kettering Cancer Center · Bridgeport, Connecticut
• Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking Study
  Recruiting · Mayo Clinic · Rochester, Minnesota