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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Age ≥ 18 years
2. 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
3. Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and/or PCWG-3
4. ECOG PS ≤ 2
5. Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and/or surgery \*\*hormonal therapy allowed. Palliative radiotherapy allowed
6. Adequate organ function per local labs
7. Comply with contraception requirements
8. Written informed consent must be obtained according to local guidelines

Exclusion Criteria:

1. Known Werner Syndrome
2. Active prior or concurrent advanced-stage malignancy (some exceptions allowed including early-stage cancers)
3. Clinically relevant cardiovascular disease
4. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)
5. Known active uncontrolled infection
6. Known allergy, hypersensitivity, and/or intolerance to MOMA-341
7. Impaired GI function that may impact absorption
8. Patient is pregnant or breastfeeding
9. Known to be HIV positive, unless all of the following criteria are met:

   1. Undetectable viral load or CD4+ count ≥300 cells/μL
   2. Receiving highly active antiretroviral therapy
   3. No AIDS-related illness within the past 12 months
10. Active liver disease (some exceptions are allowed)
11. 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

About the study

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.

What is being tested

Sponsor: MOMA Therapeutics · Participants: 132 · Started: Jul 16, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06974110

Locations in the U.S.

ArizonaInvestigative Site #132, Phoenix
CaliforniaInvestigative Site #101, San Diego
FloridaInvestigative Site #128, Tampa
MichiganInvestigative Site #120, Detroit
MissouriInvestigative Site #110, St Louis
North CarolinaInvestigative Site #131, Raleigh
OregonInvestigative Site #121, Portland
TexasInvestigative Site #129, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.