This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-313 administered orally as a single agent or combination therapy in patients with homologous recombinant deficient solid tumors.
Age ≥ 18 years
Treatment Arm 1 (MOMA-313 Monotherapy)
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.
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
Sequential
MOMA-313
DrugMOMA-313 administered orally
Olaparib
DrugOlaparib administered orally
Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation
To assess the safety and tolerability of MOMA-313 given as a single-agent or in combination with olaparib
Identify the recommended phase 2 dose (RP2D)
Determine the RP2D of MOMA-313 as a single-agent or in combination with olaparib
PK parameter: area under curve (AUC) of MOMA-313
PK parameter: maximum concentration (Cmax) of MOMA-313
PK parameter: time to maximum concentration of MOMA-313
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