RECRUITING

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

Conditions

Advanced Solid Tumor Metastatic Solid Tumor Endometrial Cancer MSI-H Cancer Colorectal Cancer Gastric Cancer dMMR Cancer Phase 1 MOMA-341 Werner helicase WRN

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants With Advanced or Metastatic Solid Tumors

Quick Facts

Study Start:2025-07-16

Study Completion:2028-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06974110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥ 18 years 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 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	1. Known Werner Syndrome 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

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 18 years
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
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

1. Known Werner Syndrome
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

Contacts and Locations

Study Contact

MOMA Clinical Trials

CONTACT

857-285-3677

clinicaltrials@momatx.com

Study Locations (Sites)

Investigative Site #127

Dallas, Texas, 75230

United States

Collaborators and Investigators

Sponsor: MOMA Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-16

Study Completion Date2028-05

Study Record Updates

Study Start Date2025-07-16

Study Completion Date2028-05

Terms related to this study

Keywords Provided by Researchers

Phase 1
MOMA-341
Werner helicase
WRN
Advanced Solid Tumor
Metastatic Solid Tumor
Gastric Cancer
Colorectal Cancer
Endometrial Cancer
MSI-H Cancer
dMMR Cancer

Additional Relevant MeSH Terms

Advanced Solid Tumor
Metastatic Solid Tumor
Endometrial Cancer
MSI-H Cancer
Colorectal Cancer
Gastric Cancer
dMMR Cancer