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New drug combo targets tough cancers in early trial

NCT ID NCT06545942

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Updated 2 times

Summary

This early-phase study tests a new oral drug called MOMA-313, alone or with another drug (olaparib), in people with advanced solid tumors that have certain DNA repair flaws. The main goals are to check safety and find the right dose. About 220 adults with cancers like prostate, pancreas, breast, or ovarian cancer are taking part.

What this could mean

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

Active substance
MOMA-313 (a drug taken by mouth) and olaparib (a PARP inhibitor taken by mouth)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have specific DNA repair problems.
What could go wrong
This is a very early Phase 1 trial focused on safety and dosing, not on proving the drug works. It is small and may not lead to an approved 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 220 people

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

Started

Aug 2024

Expected to finish

Nov 2027

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: 1. Age ≥ 18 years 2. Have histologically confirmed disease for each treatment arm as follows: 1. Treatment Arm 1 (MOMA-313 Monotherapy) \- Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, with any HR-deficient alteration. 2. Treatment Arm 2 (MOMA-313 in Combination with Olaparib): * Dose escalation: Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, for which a PARP inhibitor is indicated, with select HR-deficient mutations. Patients may be PARP inhibitor naive or exposed. * Dose optimization: Advanced (including locally), relapsed or metastatic CRPC or pancreatic ductal adenocarcinoma (PDAC) with select HR-deficient mutations. Patients must be PARP inhibitor naive. 3. Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and/or PCWG-3 4. ECOG PS ≤ 2 5. Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and/or surgery \*\*hormonal therapy allowed. Palliative radiotherapy allowed. 6. Adequate organ function per local labs 7. Comply with contraception requirements 8. Written informed consent must be obtained according to local guidelines Key Exclusion Criteria: 1. Active prior or concurrent malignancy (some exceptions allowed) 2. Clinically relevant cardiovascular disease 3. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed) 4. Known active infection 5. Prior polymerase theta inhibitor exposure 6. Known allergy, hypersensitivity, and/or intolerance to MOMA-313 7. Olaparib exposed patients with known hypersensitivity to PARP inhibitors (for patients considered for olaparib only) 8. Impaired GI function that may impact absorption. 9. Patient is pregnant or breastfeeding. 10. Known to be HIV positive, unless all of the following criteria are met: 1. Undetectable viral load or CD4+ count ≥300 cells/μL 2. Receiving highly active antiretroviral therapy 3. No AIDS-related illness within the past 12 months 11. Active liver disease (some exceptions are allowed) 12. Prior or ongoing condition, therapy, or laboratory abnormality that, in the investigator's opinion, may affect safety of the patient, confound the results of the study, and/or interfere with the patients participation in the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    14 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

  • Investigative Site #101

    RECRUITING

    La Jolla, California, 92093, United States

  • Investigative Site #102

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Investigative Site #103

    RECRUITING

    New York, New York, 10016, United States

  • Investigative Site #104

    RECRUITING

    Lake Mary, Florida, 32746, United States

  • Investigative Site #105

    COMPLETED

    San Antonio, Texas, 78229, United States

  • Investigative Site #106

    RECRUITING

    New York, New York, 10065, United States

  • Investigative Site #107

    COMPLETED

    Myrtle Beach, South Carolina, 29572, United States

  • Investigative Site #108

    RECRUITING

    Goodyear, Arizona, 85338, United States

  • Investigative Site #109

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Investigative Site #110

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Investigative Site #111

    COMPLETED

    San Francisco, California, 94143, United States

  • Investigative Site #112

    COMPLETED

    Fairfax, Virginia, 22031, United States

  • Investigative Site #113

    RECRUITING

    London, United Kingdom

  • Investigative Site #114

    RECRUITING

    Barcelona, Spain

  • Investigative Site #115

    RECRUITING

    Madrid, Spain

  • Investigative Site #116

    RECRUITING

    Barcelona, Spain

  • Investigative Site #117

    RECRUITING

    Manchester, United Kingdom

  • Investigative Site #118

    RECRUITING

    Newcastle upon Tyne, United Kingdom

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