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Experimental combo therapy for advanced cancer shows early promise but trial cut short

NCT ID NCT05491317

Disease control Sponsor: Genmab Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This early-stage trial tested a new drug (GEN1042) combined with radiation, with or without another immunotherapy (pembrolizumab), in people with metastatic solid tumors that had no standard treatment options. The goal was to see if the combination was safe and could shrink tumors, including those not directly treated with radiation. Only 13 people took part before the study was stopped early.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

13 people

The number who actually took part.

Started

Mar 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Participants with histologically confirmed non-central nervous system (CNS) solid tumor that is metastatic and for whom there is no available standard therapy. * At least 18 years of age. * Signed informed consent prior to any screening procedures. * Measurable disease according to RECIST v1.1. * Life expectancy of \>3 months. * Qualify for palliative radiotherapy as an available option for disease management. * Eastern Cooperative Oncology Group (ECOG) 0-1. * Normal or adequate liver, renal, cardiac and bone marrow function. Key Exclusion Criteria: * Prior malignancy except for non-melanoma skin cancers and in situ cancers. * Condition contraindicating radiotherapy. * Rapidly progressing disease. * Active, known or suspected autoimmune disease. * History of non-infectious pneumonitis that required steroids or currently has pneumonitis. * Contraindications to the use of pembrolizumab. * Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first treatment. * Received an allogeneic tissue/solid organ transplant. * Active infection requiring systemic therapy. Note: Other protocol defined inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm metastatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-CNS tumor

Contacts and locations

Locations

  • Centre Leon Berard

    Lyon, 69008, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

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