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New biologic drug GEN1106 enters first human tests for Hard-to-Treat cancers

NCT ID NCT07416123

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This early-stage trial is testing a new biologic drug, GEN1106, in about 103 people with advanced solid tumors, including bladder cancer. The study has three parts: first, finding a safe dose; then refining it; finally, checking how well the drug shrinks tumors. All participants receive the active drug, and the trial lasts about 17 months per person.

What this could mean

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

Active substance
GEN1106 (a biologic drug given by IV infusion)
What this could lead to
If successful, this could point toward a new treatment option for people with certain advanced solid tumors, including bladder cancer.
What could go wrong
This is a very early phase 1 trial with only 103 participants. The main goal is safety, not effectiveness, and many experimental cancer drugs fail in early testing. Side effects are unknown.

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 103 people

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

Started

Apr 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 received and progressed on, been intolerant to, or be ineligible for all available standard of care (SoC) therapies known to provide a survival and/or quality of life benefit for their tumor type. These therapies should include chemotherapy, anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) therapies, enfortumab vedotin (EV), and other therapies, where applicable. * Have measurable disease according to RECIST v1.1. * Have Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1 at screening. * Part 1: Have histologically or cytologically confirmed diagnosis of cancer as specified per protocol. * Parts 2 and 3: Have histologically or cytologically confirmed diagnosis of metastatic urothelial carcinoma (mUC). Key Exclusion Criteria: * Prior treatment with topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) therapy. * Treatment with an anticancer agent within 4 weeks or for systemic therapies within 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration. * Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1 or lower, except for alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must have recovered to grade 2. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

neoplasm transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Solid tumors Urothelial carcinoma

How to take part

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

  1. The places running it

    10 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

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Hospital HM Nou Delfos

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario Quironsalud Madrid

    RECRUITING

    Madrid, 28223, Spain

  • National Cancer Center Hospital

    RECRUITING

    Chuo Ku, Tokyo, 104-0045, Japan

  • START Madrid - Centro Integral Oncologico Clara Campal

    RECRUITING

    Madrid, 28050, Spain

  • START Madrid - Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • START New York Long Island LLC

    RECRUITING

    Lake Success, New York, 11042, United States

  • South Texas Accelerated Research Therapeutics

    RECRUITING

    San Antonio, Texas, 78229, United States

  • West Cancer Center and Research Institute

    NOT_YET_RECRUITING

    Germantown, Tennessee, 38138, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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