Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors
Start Date
7/16/2025
Completion Date
5/1/2028
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.
Detailed 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
MOMA-341
Irinotecan
Immunotherapy
Conditions
Locations
Investigative Site #132
Phoenix, Arizona 85054
United States
Investigative Site #101
San Diego, California 92037
United States
Investigative Site #128
Tampa, Florida 33612
United States
Investigative Site #120
Detroit, Michigan 48201
United States
Investigative Site #110
St Louis, Missouri 63108
United States
Investigative Site #131
Raleigh, North Carolina 27710
United States
Investigative Site #121
Portland, Oregon 97239
United States
Investigative Site #127
Dallas, Texas 75230
United States
Investigative Site #129
Houston, Texas 77030
United States
Investigative Site #122
Sydney, New South Wales 2031
Australia
Investigative Site #123
Westmead, New South Wales 2145
Australia
Investigative Site #124
Woolloongabba, Queensland 4102
Australia
Investigative Site #125
Adelaide, South Australia 5000
Australia
Investigative Site #126
Clayton, Victoria 3168
Australia
Investigative Site #119
Perth, Western Australia 6009
Australia