Actively Recruiting
A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants With Advanced or Metastatic Solid Tumors
Led by MOMA Therapeutics · Updated on 2026-04-15
132
Participants Needed
14
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying MOMA-341, a new oral drug, in adults with certain advanced or metastatic solid tumors that have specific genetic changes called microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR). This Phase 1 trial aims to evaluate the safety, how the drug is processed and affects the body, and early signs of its activity when used alone or combined with other treatments. The study involves patients who have previously received certain immunotherapies or cannot receive them. Participants will receive MOMA-341 orally in different ways: alone in 21-day cycles, with the chemotherapy irinotecan in 28-day cycles, or with immunotherapy in 21-day cycles. The trial includes a dose-escalation phase where doses are gradually increased to find the best dose, followed by a dose-optimization phase to confirm this dose. The study compares these three treatment approaches to understand their effects and safety. During the trial, participants will be monitored for side effects, drug levels in their body, and tumor responses for up to 35 months. Assessments include imaging scans to track tumor changes, laboratory tests for organ function, and evaluation of adverse events. Researchers will measure outcomes like dose-limiting toxicities, recommended doses, and various measures of tumor response and survival. This long-term monitoring helps guide future development of MOMA-341 treatments.
CONDITIONS
Brief Title
Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Unresectable advanced or metastatic solid tumors with MSI-H or dMMR alterations confirmed by biopsy
- Previous treatment and progression on anti-PD-(L)1 therapy unless ineligible or lacking access
- At least one lesion suitable for imaging evaluation
- ECOG performance status of 0 to 2
- Fully recovered from effects of prior therapy, radiotherapy, or surgery
- Adequate organ function based on local lab tests
- Compliance with contraception requirements
- Provided written informed consent according to local guidelines
You will not qualify if you...
- Known Werner Syndrome
- Active prior or concurrent advanced-stage malignancy (some early-stage cancer exceptions apply)
- Clinically significant cardiovascular disease
- Known CNS metastasis with progressive neurological symptoms (stable corticosteroid use allowed)
- Active uncontrolled infection
- Known allergy or intolerance to MOMA-341
- Gastrointestinal issues that may affect drug absorption
- Pregnant or breastfeeding
- HIV positive unless viral load is undetectable, CD4+ count is at least 300 cells/µL, on antiretroviral therapy, and no AIDS illness in past 12 months
- Active liver disease (exceptions apply)
- Any condition or therapy affecting safety, study results, or participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 35 months or until treatment discontinuation
Participants receive oral MOMA-341 as a single agent or in combination with irinotecan or immunotherapy in repeated cycles to evaluate safety and determine optimal dosing.
Repeated 21-day or 28-day treatment cycles depending on treatment arm
Trial Site Locations
Total: 14 locations
1
Investigative Site #101
San Diego, California, United States, 92037
Actively Recruiting
2
Investigative Site #128
Tampa, Florida, United States, 33612
Actively Recruiting
3
Investigative Site #120
Detroit, Michigan, United States, 48201
Actively Recruiting
4
Investigative Site #110
St Louis, Missouri, United States, 63108
Actively Recruiting
5
Investigative Site #131
Raleigh, North Carolina, United States, 27710
Actively Recruiting
6
Investigative Site #121
Portland, Oregon, United States, 97239
Actively Recruiting
7
Investigative Site #127
Dallas, Texas, United States, 75230
Actively Recruiting
8
Investigative Site #129
Houston, Texas, United States, 77030
Actively Recruiting
9
Investigative Site #122
Sydney, New South Wales, Australia, 2031
Actively Recruiting
10
Investigative Site #123
Westmead, New South Wales, Australia, 2145
Actively Recruiting
11
Investigative Site #124
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
12
Investigative Site #125
Adelaide, South Australia, Australia, 5000
Actively Recruiting
13
Investigative Site #126
Clayton, Victoria, Australia, 3168
Actively Recruiting
14
Investigative Site #119
Perth, Western Australia, Australia, 6009
Actively Recruiting
Research Team
M
MOMA Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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