Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors

Part of paid clinical trials in San Diego, California.

Sponsor
MOMA Therapeutics
Study ID
NCT06974110
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MOMA-341 — DRUG
    MOMA-341 administered orally
  • Irinotecan — DRUG
    Irinotecan administered by IV infusion
  • Immunotherapy — DRUG
    Immunotherapy administered by IV infusion

Study Details

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.

Key Dates

Start date
Jul 16, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MOMA-341 Monotherapy (Treatment Arm 1)
    MOMA-341 administered as a single agent in 21-day cycles
  • Experimental: MOMA-341 in Combination with Irinotecan (Treatment Arm 2)
    MOMA-341 administered together with irinotecan in 28-day cycles
  • Experimental: MOMA-341 in Combination with Immunotherapy (Treatment Arm 3)
    MOMA-341 administered together with immunotherapy in 21-day cycles

Primary Outcome Measure

Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation [ Time Frame: From screening until treatment discontinuation (up to 35 months) ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Investigative Site #101San DiegoCalifornia92037-
Investigative Site #128TampaFlorida33612-
Investigative Site #120DetroitMichigan48201-
Investigative Site #110St LouisMissouri63108-
Investigative Site #131RaleighNorth Carolina27710-
Investigative Site #121PortlandOregon97239-
Investigative Site #127DallasTexas75230-
Investigative Site #129HoustonTexas77030-

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