RECRUITING

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

Conditions

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

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

Official Title

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

Quick Facts

Study Start:2024-08-13

Study Completion:2027-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06545942

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. Have histologically confirmed disease for each treatment arm as follows: 1. Treatment Arm 1 (MOMA-313 Monotherapy) 2. Treatment Arm 2 (MOMA-313 in Combination with Olaparib): * Dose escalation: Advanced 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: Metastatic prostate cancer, metastatic breast cancer, or metastatic pancreatic cancer with select HR-deficient mutations. Patients must be PARP inhibitor naive. 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. Active prior or concurrent malignancy (some exceptions allowed) 2. Clinically relevant cardiovascular disease 3. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed) 4. Known active infection 5. Prior polymerase theta inhibitor exposure 6. Known allergy, hypersensitivity, and/or intolerance to MOMA-313 7. Olaparib exposed patients with significant toxicity or known hypersensitivity to PARP inhibitors (for patients considered for olaparib only) 8. Impaired GI function that may impact absorption. 9. Patient is pregnant or breastfeeding. 10. 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 11. Active liver disease (some exceptions are allowed) 12. 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. Have histologically confirmed disease for each treatment arm as follows:
1. Treatment Arm 1 (MOMA-313 Monotherapy)
2. Treatment Arm 2 (MOMA-313 in Combination with Olaparib):
* Dose escalation: Advanced 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: Metastatic prostate cancer, metastatic breast cancer, or metastatic pancreatic cancer with select HR-deficient mutations. Patients must be PARP inhibitor naive.
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. Active prior or concurrent malignancy (some exceptions allowed)
2. Clinically relevant cardiovascular disease
3. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)
4. Known active infection
5. Prior polymerase theta inhibitor exposure
6. Known allergy, hypersensitivity, and/or intolerance to MOMA-313
7. Olaparib exposed patients with significant toxicity or known hypersensitivity to PARP inhibitors (for patients considered for olaparib only)
8. Impaired GI function that may impact absorption.
9. Patient is pregnant or breastfeeding.
10. 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
11. Active liver disease (some exceptions are allowed)
12. 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

Saint Louis, Missouri, 63110

United States

Investigative Site

New York, New York, 10016

United States

Investigative Site

Myrtle Beach, South Carolina, 29572

United States

Investigative Site

San Antonio, Texas, 78229

United States

Investigative Site

Fairfax, Virginia, 22031

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 Date2024-08-13

Study Completion Date2027-11-30

Study Record Updates

Study Start Date2024-08-13

Study Completion Date2027-11-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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