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

Eligibility Criteria

• 1. Age ≥ 18 years
• 2. Have histologically confirmed disease for each treatment arm as follows:
• 1. Treatment Arm 1 (MOMA-313 Monotherapy)
• 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
• 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 significant toxicity or 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