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Clinical Trials in the USA / NCT06974110
Recruiting Phase 1

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

NCT06974110 · tracked via the Priya Life Science USA tracker
Sponsor
MOMA Therapeutics
Phase
Phase 1
Started
2025-07-16
Last updated
2026-07-23

Condition(s) studied

Advanced Solid TumorMetastatic Solid TumorEndometrial CancerMSI-H CancerColorectal CancerGastric CancerdMMR Cancer

Investigational drug(s) / intervention(s)

MOMA-341IrinotecanImmunotherapy

MOMA-341: MOMA-341 administered orally

Irinotecan: Irinotecan administered by IV infusion

Immunotherapy: Immunotherapy administered by IV infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (15)

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

More MOMA Therapeutics trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06974110 on ClinicalTrials.gov ↗ ← All trials in the USA