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New drug GEN1119 aims to fight solid tumors that resist standard care

NCT ID NCT07695831

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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Sep 09, 2026 · Updated 5 times

Summary

This trial investigates a new drug called GEN1119 for people with certain solid tumors that have not improved with standard treatments or for whom no standard treatment exists. The study is divided into parts: first, to find safe and effective doses, then to test those doses in more people with specific cancer types. All participants receive the active drug, and the trial monitors safety and tumor response over about 18 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GEN1119
What this could lead to
If successful, this could provide a new treatment option for people with solid tumors that have not responded to standard therapies.
What could go wrong
This is an early-stage trial, so the drug may not be effective or could have unexpected side effects. The results are preliminary and may not lead to a widely available treatment.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 112 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jun 2029

An estimate. End dates often move.

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: * Have histologically or cytologically confirmed diagnosis of protocol-specified solid tumours. * Have progressed on standard of care (SoC) therapy applicable for the tumor type, or for whom there is no available SoC therapy likely to provide clinical benefit, and for whom experimental therapy with GEN1119 may be a suitable option in the opinion of the investigator. * Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Have acceptable laboratory test results before GEN1119 administration per protocol Key Exclusion Criteria: * Prior treatment with certain protocol-defined therapy. * Prior treatment with T-cell engagers, chimeric antigen receptor T-cell (CAR-T-cell) therapies, other protocol defined therapies, or other therapeutic moieties targeting certain protocol-defined molecules. * Treatment with an anticancer agent within 4 weeks or within 5 half lives of the drug, whichever is shorter, but not within 2 weeks before Cycle 1 Day 1 (C1D1). * Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or lower, except for anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy, which must have recovered to ≤ Grade 2. There is no limitation for alopecia from previous therapies. * Participant should not have active Hepatitis B infection. Participants with prior infections or chronic infections are allowed if monitored or treated as per local SOC and are negative for hepatitis B virus (HBV) DNA measured viral load. * Hepatitis C virus (HCV): Known active HCV infection (defined as positive for HCV ribonucleic acid \[RNA\] \[qualitative\]). Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Solid tumours

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Eugene Marquis

    RECRUITING

    Rennes, Ille Et Vilaine, 35042, France

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, Osaka, 573-1191, Japan

  • National Cancer Center Hospital

    RECRUITING

    Chuo Ku, Tokyo, 104-0045, Japan

  • START - Hospital HM Nou Delfos

    RECRUITING

    Barcelona, Catalonia, 08023, Spain

  • START Madrid - Hospital Universitario Fundacion Jimenez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • The Cancer Institute Hospital Of JFCR

    RECRUITING

    Koto-Ku, Tokyo, 135-8550, Japan

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