Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors

Eligibility Criteria

• 1. Age ≥ 18 years
• 2. Participants have unresectable advanced or metastatic solid tumors with MSI-H or dMMR alterations and histologically confirmed disease. Participants must have previously received and progressed on an anti-PD-(L)1-based regimen
• 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. Known Werner Syndrome
• 2. Active prior or concurrent advanced-stage malignancy (some exceptions allowed including early-stage cancers)
• 3. Clinically relevant cardiovascular disease
• 4. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)
• 5. Known active uncontrolled infection
• 6. Known allergy, hypersensitivity, and/or intolerance to MOMA-341
• 7. Impaired GI function that may impact absorption
• 8. Patient is pregnant or breastfeeding
• 9. 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
• 10. Active liver disease (some exceptions are allowed)
• 11. 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