Status:
RECRUITING
Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors
Lead Sponsor:
MOMA Therapeutics
Conditions:
Advanced Solid Tumor
Metastatic Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 clini...
Detailed Description
MOMA-341 is a novel therapeutic agent designed to target microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) cancers by inhibiting Werner helicase. MOMA-341 is being devel...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06974110
Start Date
July 16 2025
End Date
May 1 2028
Last Update
November 18 2025
Active Locations (11)
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1
Investigative Site #128
Tampa, Florida, United States, 33612
2
Investigative Site #120
Detroit, Michigan, United States, 48201
3
Investigative Site #110
St Louis, Missouri, United States, 63108
4
Investigative Site #131
Raleigh, North Carolina, United States, 27710