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Experimental cocktail targets Hard-to-Treat cancers

NCT ID NCT04855656

Disease control Sponsor: Debiopharm International SA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 25, 2026 · Updated 4 times

Summary

This early-stage trial is testing a new drug called lunresertib, alone or combined with two other experimental drugs (RP-3500 and Debio 0123), in people with advanced solid tumors that have not responded to standard treatments. The study aims to find safe doses and check for early signs of tumor shrinkage. About 464 participants aged 12 and older will take part.

What this could mean

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

Active substance
lunresertib (PKMYT1 inhibitor), RP-3500 (ATR inhibitor), Debio 0123 (WEE1 inhibitor)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early Phase 1 trial, so the main goals are safety and dosing—not yet proving the drugs work. Many drug combinations fail in early testing, and side effects may limit their 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 464 people

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

Started

Apr 2021

Expected to finish

Jun 2028

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

12 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: * Male or female and ≥12 years-of-age at the time of informed consent. * Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, (or 2 for module 1) for patients \>16 years of age. * Locally advanced or metastatic resistant or refractory solid tumors. * Patients \<18 years of age must weigh at least 40 kg. * Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible * Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarker. * CCNE1 amplification (non-equivocal) as determined by either a tumor or plasma NGS test, or FISH * FBXW7 deleterious mutations identified by either a tumor or plasma NGS test * PPP2R1A deleterious mutations identified by either a tumor or plasma NGS test * Measurable disease as per RECIST v1.1. For certain modules, patients with prostate cancer or ovarian cancer that have non-measurable disease but have elevated tumor markers (PSA or CA-125, respectively) can also be eligible * Ability to swallow and retain oral medications. * Acceptable hematologic and organ function at screening. * Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening. * Resolution of all toxicities of prior therapy or surgical procedures. * Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment. Exclusion Criteria: * Chemotherapy or small molecule antineoplastic agent given within 21 days or \<5 half-lives, whichever is shorter, prior to first dose of study drug. * History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment. * Patients who are pregnant or breastfeeding. * Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety. * Major surgery within 4 weeks prior to first dose of lunresertib. * Uncontrolled, symptomatic brain metastases. * Uncontrolled hypertension. * Certain prior anti-cancer therapy * Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

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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.

Advanced solid tumor

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    21 sites in 5 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • # 1019, UCLA, Westwood Cancer Center

    COMPLETED

    Los Angeles, California, 90095, United States

  • #1001, The University of Texas M.D. Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • #1002, Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • #1004, Memorial Sloan Kettering Cancer Institute

    RECRUITING

    New York, New York, 10065, United States

  • #1007, Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • #1008, Columbia University

    COMPLETED

    New York, New York, 10032, United States

  • #1010, University of Pennsylvania

    COMPLETED

    Philadelphia, Pennsylvania, 19104, United States

  • #1011, Washington University

    RECRUITING

    St Louis, Missouri, 63130, United States

  • #1012, Yale

    RECRUITING

    New Haven, Connecticut, 06520, United States

  • #1013, The University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • #1016, Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55902, United States

  • #1017, Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • #1023, START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • #1025, University of California San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

  • #1027, University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • #1030, Women & Infants Hospital of Rhode Island

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • #1032, Northwell Health Cancer Institute

    RECRUITING

    New Hyde Park, New York, 11042, United States

  • #2001, Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2C1, Canada

  • #2002, The Hospital for Sick Children

    COMPLETED

    Toronto, Ontario, M5G 1X8, Canada

  • #2003, The Research Institute of the McGill University Health Centre

    COMPLETED

    Montreal, Quebec, H4A 3J1, Canada

  • #3003, Sarah Cannon Research Institute

    RECRUITING

    London, W1G 6AD, United Kingdom

  • #4001, Rigshospitalet - Blegdamsvej

    RECRUITING

    Copenhagen, Denmark

  • Clinica Universidad de Navarra

    NOT_YET_RECRUITING

    Madrid, 28027, Spain

  • Clinica Universidad de Navarra

    NOT_YET_RECRUITING

    Navarra, 31008, Spain

  • Hospital Universitario HM Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • START Madrid. Hospital Fundación Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

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