New drug combo targets tough cancers in early trial
NCT ID NCT06545942
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 220 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
14 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Investigative Site #101
RECRUITINGLa Jolla, California, 92093, United States
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Investigative Site #102
RECRUITINGNashville, Tennessee, 37203, United States
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Investigative Site #103
RECRUITINGNew York, New York, 10016, United States
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Investigative Site #104
RECRUITINGLake Mary, Florida, 32746, United States
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Investigative Site #105
COMPLETEDSan Antonio, Texas, 78229, United States
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Investigative Site #106
RECRUITINGNew York, New York, 10065, United States
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Investigative Site #107
COMPLETEDMyrtle Beach, South Carolina, 29572, United States
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Investigative Site #108
RECRUITINGGoodyear, Arizona, 85338, United States
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Investigative Site #109
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Investigative Site #110
RECRUITINGSt Louis, Missouri, 63110, United States
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Investigative Site #111
COMPLETEDSan Francisco, California, 94143, United States
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Investigative Site #112
COMPLETEDFairfax, Virginia, 22031, United States
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Investigative Site #113
RECRUITINGLondon, United Kingdom
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Investigative Site #114
RECRUITINGBarcelona, Spain
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Investigative Site #115
RECRUITINGMadrid, Spain
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Investigative Site #116
RECRUITINGBarcelona, Spain
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Investigative Site #117
RECRUITINGManchester, United Kingdom
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Investigative Site #118
RECRUITINGNewcastle upon Tyne, United Kingdom
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Other studies related to the condition(s) this trial covers.
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- Tiny magnetic seeds could guide surgeons to the right lymph node
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- New PET tracer aims to light up hidden cancer targets