Phase
Condition
Colon Cancer; Rectal Cancer
Rectal Cancer
Colorectal Cancer
Treatment
MOMA-341
Irinotecan
Immunotherapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years
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
Have at least 1 lesion at baseline (measurable or non-measurable) suitable forrepeat imaging evaluation by RECIST and/or PCWG-3
ECOG PS ≤ 2
Fully recovered from clinically relevant effects of prior therapy, radiotherapy,and/or surgery **hormonal therapy allowed. Palliative radiotherapy allowed
Adequate organ function per local labs
Comply with contraception requirements
Written informed consent must be obtained according to local guidelines
Exclusion
Exclusion Criteria:
Known Werner Syndrome
Active prior or concurrent advanced-stage malignancy (some exceptions allowedincluding early-stage cancers)
Clinically relevant cardiovascular disease
Known CNS metastasis associated with progressive neurological symptoms (stable dosesof corticosteroids allowed)
Known active uncontrolled infection
Known allergy, hypersensitivity, and/or intolerance to MOMA-341
Impaired GI function that may impact absorption
Patient is pregnant or breastfeeding
Known to be HIV positive, unless all of the following criteria are met:
Undetectable viral load or CD4+ count ≥300 cells/μL
Receiving highly active antiretroviral therapy
No AIDS-related illness within the past 12 months
Active liver disease (some exceptions are allowed)
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
Study Description
Connect with a study center
Investigative Site #122
Sydney, New South Wales
AustraliaSite Not Available
Investigative Site #122
Sydney 2147714, New South Wales 2155400 2031
AustraliaActive - Recruiting
Investigative Site #123
Westmead 2143973, New South Wales 2155400 2145
AustraliaActive - Recruiting
Investigative Site #124
Woolloongabba 6943568, Queensland 2152274 4102
AustraliaActive - Recruiting
Investigative Site #125
Adelaide 2078025, South Australia 2061327 5000
AustraliaActive - Recruiting
Investigative Site #126
Clayton 2171400, Victoria 2145234 3168
AustraliaActive - Recruiting
Investigative Site #119
Perth, Western Australia
AustraliaSite Not Available
Investigative Site #119
Perth 2063523, Western Australia 2058645 6009
AustraliaActive - Recruiting
Investigative Site #123
Westmead,
AustraliaSite Not Available
Investigative Site #128
Tampa 4174757, Florida 4155751 33612
United StatesActive - Recruiting
Investigative Site #120
Detroit 4990729, Michigan 5001836 48201
United StatesActive - Recruiting
Investigative Site #110
St Louis 4407066, Missouri 4398678 63108
United StatesActive - Recruiting
Investigative Site #131
Raleigh 4487042, North Carolina 4482348 27710
United StatesActive - Recruiting
Investigative Site #121
Portland 5746545, Oregon 5744337 97239
United StatesActive - Recruiting
Investigative Site #127
Dallas, Texas 75230
United StatesSite Not Available
Investigative Site #127
Dallas 4684888, Texas 4736286 75230
United StatesActive - Recruiting
Investigative Site #129
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting

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