Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors (NCT06545942) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
United States220 participantsStarted 2024-08-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years
✓. Have histologically confirmed disease for each treatment arm as follows:
✓. Treatment Arm 1 (MOMA-313 Monotherapy)
✓. Treatment Arm 2 (MOMA-313 in Combination with Olaparib):
✓. 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
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
What they're measuring
1
Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation
Timeframe: From screening until treatment discontinuation (up to 35 months)