Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06974110

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

Led by MOMA Therapeutics · Updated on 2026-04-15

132

Participants Needed

14

Research Sites

145 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Unresectable advanced or metastatic solid tumors with MSI-H or dMMR confirmed by tissue analysis
  • Must have progressed after anti-PD-(L)1 therapy unless ineligible or without access to such treatments
  • Have at least one lesion measurable or suitable for imaging evaluation
  • ECOG performance status of 2 or less
  • Fully recovered from prior therapy effects; hormonal and palliative radiotherapy allowed
  • Adequate organ function based on local laboratory tests
  • Must follow contraception requirements
  • Provide written informed consent according to local rules
Not Eligible

You will not qualify if you...

  • Known Werner Syndrome
  • Active prior or concurrent advanced-stage cancers (some early-stage cancers allowed)
  • Clinically relevant heart or cardiovascular disease
  • Known brain metastases with worsening neurological symptoms (stable corticosteroid doses allowed)
  • Active uncontrolled infections
  • Allergy, hypersensitivity, or intolerance to MOMA-341
  • Impaired gastrointestinal function affecting drug absorption
  • Pregnancy or breastfeeding
  • HIV positive unless viral load is undetectable, CD4+ count at least 300 cells/µL, on therapy, and no AIDS illness in past year
  • Active liver disease (some exceptions apply)
  • Any condition or therapy that may affect patient safety, study results, or participation as judged by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Investigative Site #101

San Diego, California, United States, 92037

Actively Recruiting

2

Investigative Site #128

Tampa, Florida, United States, 33612

Actively Recruiting

3

Investigative Site #120

Detroit, Michigan, United States, 48201

Actively Recruiting

4

Investigative Site #110

St Louis, Missouri, United States, 63108

Actively Recruiting

5

Investigative Site #131

Raleigh, North Carolina, United States, 27710

Actively Recruiting

6

Investigative Site #121

Portland, Oregon, United States, 97239

Actively Recruiting

7

Investigative Site #127

Dallas, Texas, United States, 75230

Actively Recruiting

8

Investigative Site #129

Houston, Texas, United States, 77030

Actively Recruiting

9

Investigative Site #122

Sydney, New South Wales, Australia, 2031

Actively Recruiting

10

Investigative Site #123

Westmead, New South Wales, Australia, 2145

Actively Recruiting

11

Investigative Site #124

Woolloongabba, Queensland, Australia, 4102

Actively Recruiting

12

Investigative Site #125

Adelaide, South Australia, Australia, 5000

Actively Recruiting

13

Investigative Site #126

Clayton, Victoria, Australia, 3168

Actively Recruiting

14

Investigative Site #119

Perth, Western Australia, Australia, 6009

Actively Recruiting

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Research Team

M

MOMA Clinical Trials

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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