Study of MOMA-313 for Advanced Solid Tumors

This study is testing a new oral medication called MOMA-313, alone or with another oral medication called olaparib, for people with advanced or metastatic (spread to other parts of the body) solid tumors, including prostate, pancreas, and breast cancer. The main goal is to understand the safety and side effects of MOMA-313. Researchers will also look at how the body handles the medicine and if it shows any early signs of helping against cancer. You may be able to join if you are 18 or older and have certain types of solid tumors that are considered "HR-deficient" (meaning they have a problem with DNA repair). This study is currently recruiting 220 participants.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know which treatment you are receiving. It involves two groups: one receiving MOMA-313 alone and another receiving MOMA-313 with olaparib.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the time you start screening until you stop treatment, which could be up to 35 months.

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NCT06545942

Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
MOMA Therapeutics
~220 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:MOMA-313Olaparib

At a glance

Recruiting sites
14 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation
Measured over From screening until treatment discontinuation (up to 35 months)
Advanced Solid Tumor
Metastatic Solid Tumor
Prostate Cancer
Pancreas Cancer
Breast Cancer
Ovarian Cancer
Homologous Recombination Deficiency
18 sites across 12 states
Spain3
United Kingdom3
California2
New York2
Arizona1
Florida1
Missouri1
Pennsylvania1

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Eligibility criteria

Inclusion

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
  • Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuationFrom screening until treatment discontinuation (up to 35 months)

    To assess the safety and tolerability of MOMA-313 given as a single-agent or in combination with olaparib