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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor, Metastatic Solid Tumor, Endometrial Cancer, MSI-H Cancer, Colorectal Cancer, Gastric Cancer, dMMR Cancer

In brief

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 facts

Study ID

NCT06974110

Run by

MOMA Therapeutics

People needed

132

Starts

2025-07-16

Expected to finish

2028-05-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• Known active uncontrolled infection
• Known allergy, hypersensitivity, and/or intolerance to MOMA-341
• Impaired GI function that may impact absorption
• Patient is pregnant or breastfeeding
• Known to be HIV positive, unless all of the following criteria are met:
• Undetectable viral load or CD4+ count ≥300 cells/μL
• Receiving highly active antiretroviral therapy
• No AIDS-related illness within the past 12 months
• Active liver disease (some exceptions are allowed)
• Prior or ongoing condition, therapy, or laboratory abnormality that, in the investigator's opinion, may affect safety of the patient, confound the results of the study, and/or interfere with the patients participation in the study

Where it is running

• Investigative Site #132 — Phoenix, Arizona, United States (enrolling)
• Investigative Site #101 — San Diego, California, United States (enrolling)
• Investigative Site #128 — Tampa, Florida, United States (enrolling)
• Investigative Site #120 — Detroit, Michigan, United States (enrolling)
• Investigative Site #110 — St Louis, Missouri, United States (enrolling)
• Investigative Site #131 — Raleigh, North Carolina, United States (enrolling)
• Investigative Site #121 — Portland, Oregon, United States (enrolling)
• Investigative Site #126 — Clayton, Victoria, Australia (enrolling)
• Investigative Site #119 — Perth, Western Australia, Australia (enrolling)
• Investigative Site #129 — Houston, Texas, United States (enrolling)
• Investigative Site #122 — Sydney, New South Wales, Australia (enrolling)
• Investigative Site #123 — Westmead, New South Wales, Australia (enrolling)
• Investigative Site #125 — Adelaide, South Australia, Australia (enrolling)
• Investigative Site #127 — Dallas, Texas, United States
• Investigative Site #124 — Woolloongabba, Queensland, Australia

Full record on ClinicalTrials.gov

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