NCT06545942

Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors

A Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 220 (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-313 administered orally as a single agent or combination therapy in patients with homologous recombinant deficient solid tumors.

Detailed description

MOMA-313 is a novel therapeutic agent designed to target homologous recombination (HR)-deficient cancers by inhibiting DNA polymerase theta. MOMA-313 is being developed as a single-agent and in combination with a poly (adenosine diphosphate ribose) polymerase (PARP) inhibitor in patients with HR-deficient advanced (including locally), relapsed or metastatic solid tumors. This phase 1, first-in-human, open-label study of MOMA-313 is primarily intended to evaluate the safety and tolerability of MOMA-313 when administered orally as a single agent (Treatment Arm 1) or in combination with olaparib (Treatment Arm 2). Each treatment arm of the study includes a dose-escalation phase followed by a dose-optimization phase. In the dose-escalation phase of each treatment arm, successive cohorts of patients will receive increasing oral doses of MOMA-313 as a single agent or in combination with olaparib to determine the presumptive optimal biologic dose(s) (OBD) in this population. The dose-optimization phase of each arm will enroll additional patients to support the confirmation of the OBD. The data from this study conducted in patients with HR-deficient advanced (including locally), relapsed or metastatic solid tumors, including safety, tolerability, PK/PDx findings, and antitumor activity, will form the basis for subsequent clinical development of MOMA-313 as a single-agent and in combination with olaparib.

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Prostate Cancer
• Pancreas Cancer
• Breast Cancer
• Ovarian Cancer
• Homologous Recombination Deficiency

Interventions

Type	Name	Description
DRUG	MOMA-313	MOMA-313 administered orally
DRUG	Olaparib	Olaparib administered orally

Timeline

• Start date: 2024-08-13
• Primary completion: 2027-05-31
• Completion: 2027-11-30
• First posted: 2024-08-09
• Last updated: 2026-04-17

Locations

18 sites across 3 countries: United States, Spain, United Kingdom

Regulatory

• FDA-regulated drug study