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

NCT06974110 | Recruiting Phase 1 FDA Drug

• 1 other identifier: MOMA-341-001
• Study Type: interventional
• Target: 132
• Locations: 2 countries
• Sites: 14

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation

  To assess the safety and tolerability of MOMA-341 given as a single-agent, and in combination with irinotecan, and in combination with immunotherapy

  From screening until treatment discontinuation (up to 35 months)

Secondary Outcomes (12)

• Identify the recommended phase 2 dose (RP2D)

  From screening until treatment discontinuation (up to 35 months)

• PK parameter; area under curve (AUC) of MOMA-341

  Up to 6 weeks with sparse sampling up to 35 months

• PK parameter; maximum concentration (Cmax) of MOMA-341

  Up to 6 weeks with sparse sampling up to 35 months

• PK parameter; time to maximum concentration (Tmax) of MOMA-341

  Up to 6 weeks with sparse sampling up to 35 months

• PK parameter; half-life (T1/2) of MOMA-341

  Up to 6 weeks with sparse sampling up to 35 months

Study Arms (3)

MOMA-341 Monotherapy (Treatment Arm 1)

EXPERIMENTAL

MOMA-341 administered as a single agent in 21-day cycles

Drug: MOMA-341

MOMA-341 in Combination with Irinotecan (Treatment Arm 2)

EXPERIMENTAL

MOMA-341 administered together with irinotecan in 28-day cycles

Drug: MOMA-341; Drug: Irinotecan

MOMA-341 in Combination with Immunotherapy (Treatment Arm 3)

EXPERIMENTAL

MOMA-341 administered together with immunotherapy in 21-day cycles

Drug: MOMA-341; Drug: Immunotherapy

Interventions

MOMA-341 DRUG

MOMA-341 administered orally

MOMA-341 Monotherapy (Treatment Arm 1); MOMA-341 in Combination with Immunotherapy (Treatment Arm 3); MOMA-341 in Combination with Irinotecan (Treatment Arm 2)

Irinotecan DRUG

Irinotecan administered by IV infusion

MOMA-341 in Combination with Irinotecan (Treatment Arm 2)

Immunotherapy DRUG

Immunotherapy administered by IV infusion

MOMA-341 in Combination with Immunotherapy (Treatment Arm 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• 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
• Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat 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

You may not qualify if:

• Known Werner Syndrome
• Active prior or concurrent advanced-stage malignancy (some exceptions allowed including early-stage cancers)
• Clinically relevant cardiovascular disease
• Known CNS metastasis associated with progressive neurological symptoms (stable doses of 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 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

Sponsors & Collaborators

• MOMA Therapeutics: lead

Study Sites (14)

Investigative Site #101

San Diego, California, 92037, United States

RECRUITING

Investigative Site #128

Tampa, Florida, 33612, United States

RECRUITING

Investigative Site #120

Detroit, Michigan, 48201, United States

RECRUITING

Investigative Site #110

St Louis, Missouri, 63108, United States

RECRUITING

Investigative Site #131

Raleigh, North Carolina, 27710, United States

RECRUITING

Investigative Site #121

Portland, Oregon, 97239, United States

RECRUITING

Investigative Site #127

Dallas, Texas, 75230, United States

RECRUITING

Investigative Site #129

Houston, Texas, 77030, United States

RECRUITING

Investigative Site #122

Sydney, New South Wales, 2031, Australia

RECRUITING

Investigative Site #123

Westmead, New South Wales, 2145, Australia

RECRUITING

Investigative Site #124

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Investigative Site #125

Adelaide, South Australia, 5000, Australia

RECRUITING

Investigative Site #126

Clayton, Victoria, 3168, Australia

RECRUITING

Investigative Site #119

Perth, Western Australia, 6009, Australia

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Endometrial Neoplasms; Colorectal Neoplasms; Stomach Neoplasms

Interventions

Irinotecan; Immunotherapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

MOMA Clinical Trials

CONTACT

857-285-3677; clinicaltrials@momatx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 15, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

AU (6); US (8)