Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors
NCT ID: NCT06974110
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
132 participants
INTERVENTIONAL
2025-07-16
2028-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MOMA-341 Monotherapy (Treatment Arm 1)
MOMA-341 administered as a single agent in 21-day cycles
MOMA-341
MOMA-341 administered orally
MOMA-341 in Combination with Irinotecan (Treatment Arm 2)
MOMA-341 administered together with irinotecan in 28-day cycles
MOMA-341
MOMA-341 administered orally
Irinotecan
Irinotecan administered by IV infusion
MOMA-341 in Combination with Immunotherapy (Treatment Arm 3)
MOMA-341 administered together with immunotherapy in 21-day cycles
MOMA-341
MOMA-341 administered orally
Immunotherapy
Immunotherapy administered by IV infusion
Interventions
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MOMA-341
MOMA-341 administered orally
Irinotecan
Irinotecan administered by IV infusion
Immunotherapy
Immunotherapy administered by IV infusion
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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MOMA Therapeutics
INDUSTRY
Responsible Party
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Locations
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Investigative Site #128
Tampa, Florida, United States
Investigative Site #120
Detroit, Michigan, United States
Investigative Site #110
St Louis, Missouri, United States
Investigative Site #131
Raleigh, North Carolina, United States
Investigative Site #121
Portland, Oregon, United States
Investigative Site #127
Dallas, Texas, United States
Investigative Site #129
Houston, Texas, United States
Investigative Site #122
Sydney, New South Wales, Australia
Investigative Site #123
Westmead, New South Wales, Australia
Investigative Site #124
Woolloongabba, Queensland, Australia
Investigative Site #125
Adelaide, South Australia, Australia
Investigative Site #126
Clayton, Victoria, Australia
Investigative Site #119
Perth, Western Australia, Australia
Countries
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Central Contacts
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Other Identifiers
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MOMA-341-001
Identifier Type: -
Identifier Source: org_study_id
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