Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors (NCT06974110) | Clinical Trial Compass
RecruitingPhase 1
Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors
United States132 participantsStarted 2025-07-16
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-341 administered orally as a single agent or combination therapy in patients with microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years
✓. 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, unless ineligible or in a region without access to anti-PD-(L)1 therapies
✓. 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
Exclusion criteria
✕. Known Werner Syndrome
✕. Active prior or concurrent advanced-stage malignancy (some exceptions allowed including early-stage cancers)
✕. Clinically relevant cardiovascular disease
✕. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)
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)