Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
NCT Number: NCT06545942
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumor|Metastatic Solid Tumor|Prostate Cancer|Pancreas Cancer|Breast Cancer|Ovarian Cancer|Homologous Recombination Deficiency
Interventions: DRUG: MOMA-313|DRUG: Olaparib
Sponsor: MOMA Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 158
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-13
Completion Date: 2027-11-30
Locations: Investigative Site, San Antonio, Texas, 78229, United States|Investigative Site, Fairfax, Virginia, 22031, United States

Summary:
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.

Primary Outcome Measures: 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, From screening until treatment discontinuation (up to 35 months)
Secondary Outcome Measures: Identify the recommended phase 2 dose (RP2D), Determine the RP2D of MOMA-313 as a single-agent or in combination with olaparib, From screening until treatment discontinuation (up to 35 months)|PK parameter: area under curve (AUC) of MOMA-313, Up to 6 weeks with sparse sampling up to 35 months|PK parameter: maximum concentration (Cmax) of MOMA-313, Up to 6 weeks with sparse sampling up to 35 months|PK parameter: time to maximum concentration of MOMA-313, Up to 6 weeks with sparse sampling up to 35 months|PK parameter: half-life of MOMA-313, Up to 6 weeks with sparse sampling up to 35 months|Plasma concentration of olaparib, Up to 6 weeks with sparse sampling up to 35 months|Objective response rate (ORR), ORR is defined as the percentage of subjects with evidence of a complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and/or Prostate Cancer Working Group-3 (PCWG-3)., Up to 35 months|Duration of response (DOR), DOR is defined as time from first documented PR or better to disease progression (as assessed by RECIST v1.1 and/or PCWG-3 by Investigator assessment) or death whichever is earlier for participants who have achieved a CR or PR, Up to 35 months|Time to response (TTR), TTR is defined as the period of time from the date of first dose of study treatment until the first objective documentation of a CR or PR per RECIST 1.1 and/or PCWG-3., Up to 35 months|Progression free survival (PFS), PFS is time from first dose of study treatment to progressive disease or death from any cause, whichever is earlier, as assessed via RECIST v1.1 and/or PCWG-3 by Investigator assessment, Up to 35 months|Disease control rate (DCR), DCR defined by the proportion of subjects who achieved either a complete response (CR), partial response (PR), or stable disease (SD) at their first scheduled disease assessment according to disease-specific response criteria., Up to 35 months|Overall survival (OS), OS is defined as the time from first dose of study treatment to the date of death, irrespective of the cause of death, Up to 35 months