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

Inclusion Criteria

• Age ≥ 18 years
• Have histologically confirmed disease for each treatment arm as follows:
• 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.
• 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.
• Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and/or PCWG-3
• ECOG PS ≤ 2
• Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and/or surgery **hormonal therapy allowed. Palliative radiotherapy allowed.
• Adequate organ function per local labs
• Comply with contraception requirements
• Written informed consent must be obtained according to local guidelines Key

Exclusion Criteria

• Active prior or concurrent malignancy (some exceptions allowed)
• Clinically relevant cardiovascular disease
• Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)
• Known active infection
• Prior polymerase theta inhibitor exposure
• Known allergy, hypersensitivity, and/or intolerance to MOMA-313
• Olaparib exposed patients with known hypersensitivity to PARP inhibitors (for patients considered for olaparib only)
• Impaired GI function that may impact absorption.
• Patient is pregnant or breastfeeding.
• Known to be HIV positive, unless all of the following criteria are met:
• Undetectable viral load or CD4+ count ≥300 cells/μL
• Receiving highly active antiretroviral therapy
• No AIDS-related illness within the past 12 months
• Active liver disease (some exceptions are allowed)
• 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