Oral treatment with MOMA-313 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Investigative Site #108
  Goodyear, Arizona, United States Recruiting
• Investigative Site #101
  La Jolla, California, United States Recruiting
• Investigative Site #104
  Lake Mary, Florida, United States Recruiting
• Investigative Site #110
  St Louis, Missouri, United States Recruiting
• Investigative Site #103
  New York, New York, United States Recruiting
• Investigative Site #106
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: MOMA Clinical Trials
• Email: clinicaltrials@momatx.com
• Phone: (857) 285-3677

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.