Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors
A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants With Advanced or Metastatic Solid Tumors
MOMA Therapeutics
132 participants
Jul 16, 2025
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria8
- 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 Criteria14
- 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
Interventions
MOMA-341 administered orally
Irinotecan administered by IV infusion
Immunotherapy administered by IV infusion
Locations(13)
View Full Details on ClinicalTrials.gov
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NCT06974110