Oral MOMA-341 for advanced or metastatic MSI-H or dMMR solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

MOMA-341 is a novel oral agent that targets Werner helicase (WRN) to exploit vulnerabilities in microsatellite instability-high (MSI-H) or mismatch repair–deficient (dMMR) cancers. This first-in-human, open-label Phase 1 study uses dose-escalation and dose-optimization cohorts to measure safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity. The drug will be tested as a single agent and in combination with irinotecan or with immunotherapy across successive dose cohorts to identify presumptive optimal biologic doses. Safety, PK/PDx, and antitumor activity data will inform subsequent clinical development.

Why it matters

Who can join: the full rules

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

Where it's running

• Investigative Site #132
  Phoenix, Arizona, United States Recruiting
• Investigative Site #101
  San Diego, California, United States Recruiting
• Investigative Site #128
  Tampa, Florida, United States Recruiting
• Investigative Site #120
  Detroit, Michigan, United States Recruiting
• Investigative Site #110
  St Louis, Missouri, United States Recruiting
• Investigative Site #131
  Raleigh, North Carolina, United States Recruiting

Study contacts

• Study coordinator: MOMA Clinical Trials
• Email: clinicaltrials@momatx.com
• Phone: 857-285-3677

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.