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

NCT06545942 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: MOMA-313-001
• Study Type: interventional
• Target: 220
• Locations: 3 countries
• Sites: 18

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-313 administered orally as a single agent or combination therapy in patients with homologous recombinant deficient solid tumors.

Conditions

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

Keywords

Phase 1; MOMA-313; Polymerase theta; MOMA Therapeutics; Advanced Solid Tumor; Metastatic Solid Tumor; Prostate Cancer; Pancreas Cancer; Breast Cancer; Ovarian Cancer; Homologous Recombination Deficiency; HRD Mutation; Advanced (including locally)

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-313 given as a single-agent or in combination with olaparib

  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-313

  Up to 6 weeks with sparse sampling up to 35 months

• PK parameter: maximum concentration (Cmax) of MOMA-313

  Up to 6 weeks with sparse sampling up to 35 months

• PK parameter: time to maximum concentration of MOMA-313

  Up to 6 weeks with sparse sampling up to 35 months

• PK parameter: half-life of MOMA-313

  Up to 6 weeks with sparse sampling up to 35 months

Study Arms (2)

MOMA-313 Monotherapy (Treatment Arm 1)

EXPERIMENTAL

MOMA-313 administered as a single-agent in 21-day cycles.

Drug: MOMA-313

MOMA-313 in Combination with Olaparib (Treatment Arm 2)

EXPERIMENTAL

MOMA-313 administered together with twice daily (BID) olaparib in 28-day cycles.

Drug: MOMA-313; Drug: Olaparib

Interventions

MOMA-313 DRUG

MOMA-313 administered orally

MOMA-313 Monotherapy (Treatment Arm 1); MOMA-313 in Combination with Olaparib (Treatment Arm 2)

Olaparib DRUG

Olaparib administered orally

MOMA-313 in Combination with Olaparib (Treatment Arm 2)

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
• Have histologically confirmed disease for each treatment arm as follows:
• Treatment Arm 1 (MOMA-313 Monotherapy)
• \- Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, with any HR-deficient alteration.
• Treatment Arm 2 (MOMA-313 in Combination with Olaparib):
• Dose escalation: Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, for which a PARP inhibitor is indicated, with select HR-deficient mutations. Patients may be PARP inhibitor naive or exposed.
• Dose optimization: Advanced (including locally), relapsed or metastatic CRPC or pancreatic ductal adenocarcinoma (PDAC) with select HR-deficient mutations. Patients must be PARP inhibitor naive.
• 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:

• Active prior or concurrent malignancy (some exceptions allowed)
• Clinically relevant cardiovascular disease
• Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)
• Known active infection
• Prior polymerase theta inhibitor exposure
• Known allergy, hypersensitivity, and/or intolerance to MOMA-313
• Olaparib exposed patients with known hypersensitivity to PARP inhibitors (for patients considered for olaparib only)
• 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 (18)

Investigative Site #108

Goodyear, Arizona, 85338, United States

Location

Investigative Site #101

La Jolla, California, 92093, United States

Location

Investigative Site #111

San Francisco, California, 94143, United States

Location

Investigative Site #104

Lake Mary, Florida, 32746, United States

Location

Investigative Site #110

St Louis, Missouri, 63110, United States

Location

Investigative Site #103

New York, New York, 10016, United States

Location

Investigative Site #106

New York, New York, 10065, United States

Location

Investigative Site #109

Philadelphia, Pennsylvania, 19104, United States

Location

Investigative Site #107

Myrtle Beach, South Carolina, 29572, United States

Location

Investigative Site #102

Nashville, Tennessee, 37203, United States

Location

Investigative Site #105

San Antonio, Texas, 78229, United States

Location

Investigative Site #112

Fairfax, Virginia, 22031, United States

Location

Investigative Site #114

Barcelona, Spain

Location

Investigative Site #116

Barcelona, Spain

Location

Investigative Site #115

Madrid, Spain

Location

Investigative Site #113

London, United Kingdom

Location

Investigative Site #117

Manchester, United Kingdom

Location

Investigative Site #118

Newcastle upon Tyne, United Kingdom

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Prostatic Neoplasms; Pancreatic Neoplasms; Breast Neoplasms; Ovarian Neoplasms

Interventions

olaparib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Gonadal Disorders

Study Design

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

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 9, 2024
• Study Start: August 13, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (12); ES (3); GB (3)