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Oral treatment with MOMA-313 for advanced solid tumors

A Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors

Phase 1 Interventional MOMA Therapeutics · NCT06545942

This study is testing a new oral treatment called MOMA-313 for people with advanced solid tumors that can't be cured, to see how safe it is and how well it works, especially for those with certain genetic changes.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment158 (estimated)
Ages18 Years and up
SexAll
SponsorMOMA Therapeutics Industry-sponsored
Locations15 sites (La Jolla, California and 14 other locations)
Trial IDNCT06545942 on ClinicalTrials.gov

What this trial studies

This Phase 1, multi-center, open-label study evaluates the safety and tolerability of MOMA-313, a novel agent targeting homologous recombination-deficient cancers, administered orally either alone or in combination with olaparib. The study includes a dose-escalation phase to determine optimal dosing followed by a dose-optimization phase to confirm the optimal biologic dose. Patients with advanced or metastatic solid tumors that are not eligible for curative therapy will be enrolled, focusing on those with specific genetic alterations. The study aims to gather data on pharmacokinetics, pharmacodynamics, and preliminary clinical activity of MOMA-313.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic solid tumors that are homologous recombination-deficient and not eligible for curative therapy.

Not a fit: Patients with solid tumors that are not homologous recombination-deficient or those who are eligible for curative therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are difficult to treat.

How similar studies have performed: While this approach is novel in targeting homologous recombination-deficient tumors with MOMA-313, similar studies using PARP inhibitors have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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 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: Metastatic prostate cancer, metastatic breast cancer, or metastatic pancreatic cancer 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

Where this trial is running

La Jolla, California and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumorMetastatic Solid TumorProstate CancerPancreas CancerBreast CancerOvarian CancerHomologous Recombination DeficiencyPhase 1
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.