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

Last updated: January 14, 2026
Sponsor: MOMA Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Colon Cancer; Rectal Cancer

Rectal Cancer

Colorectal Cancer

Treatment

MOMA-341

Irinotecan

Immunotherapy

Clinical Study ID

NCT06974110
MOMA-341-001
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

  2. Participants have unresectable advanced or metastatic solid tumors with MSI-H ordMMR alterations and histologically confirmed disease. Participants must havepreviously received and progressed on an anti-PD-(L)1-based regimen, unlessineligible 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 forrepeat 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

Exclusion Criteria:

  1. Known Werner Syndrome

  2. Active prior or concurrent advanced-stage malignancy (some exceptions allowedincluding early-stage cancers)

  3. Clinically relevant cardiovascular disease

  4. Known CNS metastasis associated with progressive neurological symptoms (stable dosesof 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:

  10. Undetectable viral load or CD4+ count ≥300 cells/μL

  11. Receiving highly active antiretroviral therapy

  12. No AIDS-related illness within the past 12 months

  13. Active liver disease (some exceptions are allowed)

  14. Prior or ongoing condition, therapy, or laboratory abnormality that, in theinvestigator's opinion, may affect safety of the patient, confound the results ofthe study, and/or interfere with the patients participation in the study

Study Design

Total Participants: 132
Treatment Group(s): 3
Primary Treatment: MOMA-341
Phase: 1
Study Start date:
July 16, 2025
Estimated Completion Date:
May 31, 2028

Study 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 developed as a single agent and in combination with either chemotherapy or immunotherapy in patients with certain advanced or metastatic solid tumors.

This phase 1, first-in-human, open-label study of MOMA-341 is primarily intended to evaluate the safety and tolerability of MOMA-341 when administered orally as a single agent (Treatment Arm 1), in combination with irinotecan (Treatment Arm 2), or in combination with immunotherapy (Treatment Arm 3). Each treatment arm of the study includes a dose-escalation phase, which means successive cohorts of patients will receive increasing oral doses of MOMA-341 as a single agent or in combination with irinotecan or immunotherapy to determine the presumptive optimal biologic dose(s) (OBD) in this population. The study also includes a dose-optimization phase that will enroll additional patients to support the confirmation of the OBD.

The data from this study conducted in patients with MSI-H or dMMR advanced or metastatic solid tumors, including safety, tolerability, PK/PDx findings, and antitumor activity, will form the basis for subsequent clinical development of MOMA-341 as a single-agent and in combination with irinotecan or immunotherapy.

Connect with a study center

  • Investigative Site #122

    Sydney, New South Wales
    Australia

    Site Not Available

  • Investigative Site #122

    Sydney 2147714, New South Wales 2155400 2031
    Australia

    Active - Recruiting

  • Investigative Site #123

    Westmead 2143973, New South Wales 2155400 2145
    Australia

    Active - Recruiting

  • Investigative Site #124

    Woolloongabba 6943568, Queensland 2152274 4102
    Australia

    Active - Recruiting

  • Investigative Site #125

    Adelaide 2078025, South Australia 2061327 5000
    Australia

    Active - Recruiting

  • Investigative Site #126

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Active - Recruiting

  • Investigative Site #119

    Perth, Western Australia
    Australia

    Site Not Available

  • Investigative Site #119

    Perth 2063523, Western Australia 2058645 6009
    Australia

    Active - Recruiting

  • Investigative Site #123

    Westmead,
    Australia

    Site Not Available

  • Investigative Site #128

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

  • Investigative Site #120

    Detroit 4990729, Michigan 5001836 48201
    United States

    Active - Recruiting

  • Investigative Site #110

    St Louis 4407066, Missouri 4398678 63108
    United States

    Active - Recruiting

  • Investigative Site #131

    Raleigh 4487042, North Carolina 4482348 27710
    United States

    Active - Recruiting

  • Investigative Site #121

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • Investigative Site #127

    Dallas, Texas 75230
    United States

    Site Not Available

  • Investigative Site #127

    Dallas 4684888, Texas 4736286 75230
    United States

    Active - Recruiting

  • Investigative Site #129

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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