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Experimental cancer drug enters human testing

NCT ID NCT06431594

Disease control Sponsor: GlaxoSmithKline 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage trial tests an experimental drug called mocertatug rezetecan in 675 adults with advanced solid tumors that have not responded to standard treatments. The drug is designed to deliver a toxin directly to cancer cells. The main goals are to check safety, find the right dose, and see if tumors shrink.

What this could mean

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

Active substance
mocertatug rezetecan (an experimental antibody-drug conjugate that delivers a toxin to cancer cells)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, so it is too soon to know if the drug will work. Side effects from the toxin or antibody may limit its use.

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 675 people

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

Started

Jul 2024

Expected to finish

Dec 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.

Inclusion Criteria: * Males or females aged 18 years or older (≥18 years). * Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care. * PROC cohort 1. Histologically documented, advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer. 2. Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy. 3. Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy. 4. Must have had prior bevacizumab , unless there is a documented contraindication or intolerance. 5. Participants with known Folate receptor-α (FR-α) expressing tumors must have received mirvetuximab soravtansine if the regimen is locally available, unless there is a documented contraindication or intolerance. Participants with known Breast cancer susceptibility gene (BRCA) mutated tumors should have received a Poly adenosine diphosphate-ribose polymerase (PARP) inhibitor if the regimen is locally available, unless there is a documented contraindication or intolerance. * Endometrial cancer cohort 1. Histologically documented, advanced (metastatic and/or unresectable) or recurrent endometrial cancer. 2. Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy. 3. Must have had prior platinum and PD(L)-1 inhibitor (in same regimen or in separate regimens), if the regimen is locally available, unless there is a documented contradiction or intolerance 4. All epithelial histologies are permitted including carcinosarcoma. * Participants have at least one target lesion as assessed per the RECIST 1.1 * Tumor tissue from a newly obtained biopsy or archival tumor tissue is required for retrospective detection of B7 homolog 4 (B7-H4) expression by IHC in central laboratory and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue within 2 years prior to the first dose of study drug is acceptable. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 and no deterioration within 2 weeks before the first dose. * Have a life expectancy of at least 12 weeks. Exclusion Criteria: * Have received any B7-H4-targeted therapy * Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study. * Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment. * Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion * Major surgery within 28 days prior to the first dose of study treatment. * Evidence of brain metastasis unless asymptomatic; * Has inadequate bone marrow reserve or hepatic/renal functions . * Mean Fridericia-corrected QT interval (QTcF) QTcF \>450 msec or QTcF \>480 msec for participants with bundle branch blocK; * Evidence of current clinically significant arrhythmias or ECG abnormalities * Left ventricular ejection fraction (LVEF) \< 50%. * Have severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events * Has current active pneumonitis/ILD or any history of ILD, any history of pneumonitis requiring steroids or immunomodulatory treatment within 90 days of planned randomization/enrollment or any history of drug-induced pneumonitis/ILD.Have received prior therapy with topoisomerase inhibitors or topoisomerase inhibitor Antibody-drug conjugate (ADCs) * PROC 1. Primary platinum refractory disease defined as those who have progressed on or within 12 weeks of last dose of first line platinum therapy not permitted. 2. Non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade serous, or low-grade endometrioid carcinoma not permitted. * Endometrial cancer a. Mesenchymal tumors of the uterus (uterine sarcomas) not permitted.

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Conditions

The condition(s) this trial relates to.

endometrial cancer fallopian tube cancer neoplasm ovarian endometrioid adenocarcinoma ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

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

Neoplasms Solid tumors

How to take part

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

  1. The places running it

    64 sites in 15 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

  • GSK Investigational Site

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • GSK Investigational Site

    RECRUITING

    Fountain Valley, California, 92708, United States

  • GSK Investigational Site

    RECRUITING

    Santa Rosa, California, 95403, United States

  • GSK Investigational Site

    COMPLETED

    Lake Mary, Florida, 32746, United States

  • GSK Investigational Site

    RECRUITING

    Orlando, Florida, 32827, United States

  • GSK Investigational Site

    RECRUITING

    Fairway, Kansas, 66205, United States

  • GSK Investigational Site

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • GSK Investigational Site

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • GSK Investigational Site

    RECRUITING

    Detroit, Michigan, 48201, United States

  • GSK Investigational Site

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • GSK Investigational Site

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • GSK Investigational Site

    RECRUITING

    Mineola, New York, 11501, United States

  • GSK Investigational Site

    RECRUITING

    New York, New York, 10016, United States

  • GSK Investigational Site

    RECRUITING

    Portland, Oregon, 97213, United States

  • GSK Investigational Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • GSK Investigational Site

    RECRUITING

    Dallas, Texas, 75230, United States

  • GSK Investigational Site

    RECRUITING

    West Valley City, Utah, 84119, United States

  • GSK Investigational Site

    RECRUITING

    Seattle, Washington, 98104, United States

  • GSK Investigational Site

    RECRUITING

    Cipoletti Rio Negro, R8324CVE, Argentina

  • GSK Investigational Site

    RECRUITING

    Ciudad de Buenos Aires, 1118, Argentina

  • GSK Investigational Site

    RECRUITING

    La Plata, B1900AVG, Argentina

  • GSK Investigational Site

    RECRUITING

    Rosario, S2002, Argentina

  • GSK Investigational Site

    RECRUITING

    Blacktown, New South Wales, 2148, Australia

  • GSK Investigational Site

    RECRUITING

    Macquarie University, New South Wales, 2109, Australia

  • GSK Investigational Site

    RECRUITING

    Leuven, 3000, Belgium

  • GSK Investigational Site

    RECRUITING

    Barretos, 14784-400, Brazil

  • GSK Investigational Site

    RECRUITING

    Goiânia, 74605-070, Brazil

  • GSK Investigational Site

    RECRUITING

    Rio de Janeiro, 20220-410, Brazil

  • GSK Investigational Site

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • GSK Investigational Site

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • GSK Investigational Site

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • GSK Investigational Site

    RECRUITING

    Helsinki, 00180, Finland

  • GSK Investigational Site

    RECRUITING

    Helsinki, 00290, Finland

  • GSK Investigational Site

    RECRUITING

    Tampere, 33520, Finland

  • GSK Investigational Site

    RECRUITING

    Lyon, 69373, France

  • GSK Investigational Site

    RECRUITING

    Saint-Herblain, 44805, France

  • GSK Investigational Site

    RECRUITING

    Villejuif, 94805, France

  • GSK Investigational Site

    RECRUITING

    Aviano PN, 33081, Italy

  • GSK Investigational Site

    RECRUITING

    Milan, 20141, Italy

  • GSK Investigational Site

    RECRUITING

    Milan, 20159, Italy

  • GSK Investigational Site

    RECRUITING

    Naples, 80131, Italy

  • GSK Investigational Site

    RECRUITING

    Roma, 00168, Italy

  • GSK Investigational Site

    RECRUITING

    Saitama, 350-1298, Japan

  • GSK Investigational Site

    RECRUITING

    Shizuoka, 411-8777, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 135-8550, Japan

  • GSK Investigational Site

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • GSK Investigational Site

    RECRUITING

    Gyeonggi-do, 10408, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 03080, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 03722, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 06351, South Korea

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08035, Spain

  • GSK Investigational Site

    RECRUITING

    Córdoba, 14004, Spain

  • GSK Investigational Site

    RECRUITING

    Girona, 17007, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28027, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28034, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28040, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28046, Spain

  • GSK Investigational Site

    RECRUITING

    Pozuelo de AlarcOn Madr, 28223, Spain

  • GSK Investigational Site

    RECRUITING

    Stockholm, 17164, Sweden

  • GSK Investigational Site

    RECRUITING

    Uppsala, SE-751 85, Sweden

  • GSK Investigational Site

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, NW1 2PG, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, W1G 6AD, United Kingdom

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Other studies related to the condition(s) this trial covers.