RecruitingPhase 1NCT06974110

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

A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants With Advanced or Metastatic Solid Tumors


Sponsor

MOMA Therapeutics

Enrollment

132 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral drug called MOMA-341 in people with advanced or metastatic solid tumors that have a specific DNA repair defect (called MSI-H or dMMR), which affects how cancer cells fix their DNA and makes them respond differently to treatment. **You may be eligible if...** - You are 18 or older with advanced or metastatic solid tumors confirmed by biopsy - Your tumor has been tested and found to have MSI-H (microsatellite instability-high) or dMMR (mismatch repair deficient) status - Your cancer has progressed after receiving an anti-PD-(L)1 immunotherapy (checkpoint inhibitor), unless that treatment was not available or not appropriate for you - You have acceptable organ function and are physically well (ECOG score 0–2) **You may NOT be eligible if...** - Your cancer has not been tested for MSI/MMR status, or results are negative - You have active brain metastases - You are pregnant or breastfeeding - You have uncontrolled infections or serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMOMA-341

MOMA-341 administered orally

DRUGIrinotecan

Irinotecan administered by IV infusion

DRUGImmunotherapy

Immunotherapy administered by IV infusion


Locations(14)

Investigative Site #101

San Diego, California, United States

Investigative Site #128

Tampa, Florida, United States

Investigative Site #120

Detroit, Michigan, United States

Investigative Site #110

St Louis, Missouri, United States

Investigative Site #131

Raleigh, North Carolina, United States

Investigative Site #121

Portland, Oregon, United States

Investigative Site #127

Dallas, Texas, United States

Investigative Site #129

Houston, Texas, United States

Investigative Site #122

Sydney, New South Wales, Australia

Investigative Site #123

Westmead, New South Wales, Australia

Investigative Site #124

Woolloongabba, Queensland, Australia

Investigative Site #125

Adelaide, South Australia, Australia

Investigative Site #126

Clayton, Victoria, Australia

Investigative Site #119

Perth, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT06974110


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