NCT06974110

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: MOMA Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	MOMA-341	MOMA-341 administered orally
DRUG	Irinotecan	Irinotecan administered by IV infusion
DRUG	Immunotherapy	Immunotherapy administered by IV infusion

Timeline

• Start date: 2025-07-16
• Primary completion: 2027-11-01
• Completion: 2028-05-01
• First posted: 2025-05-15
• Last updated: 2026-04-15

Locations

14 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study