NCT06545942 · MOMA Therapeutics
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
What this study is about
This Phase 1, multi-center, where both patients and doctors know the treatment given, gradually increasing doses and dose optimization study is designed to assess the safety, tolerability, how the drug moves through the body (PK), how the drug affects the body (PDx), and preliminary clinical activity of MOMA-313 administered taken by mouth as a single agent or two or more treatments used together in patients with homologous recombinant deficient solid tumors.
View original scientific 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.
Interventions
DRUG
MOMA-313
MOMA-313 administered orally
DRUG
Olaparib
Olaparib administered orally
Primary outcome measures
Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation
Time frame: From screening until treatment discontinuation (up to 35 months)
To assess the safety and tolerability of MOMA-313 given as a single-agent or in combination with olaparib
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 Key
Exclusion criteria
- 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
Where
- Goodyear, Arizona
- La Jolla, California
- San Francisco, California
- Lake Mary, Florida
- St Louis, Missouri
- New York, New York
- Philadelphia, Pennsylvania
- Myrtle Beach, South Carolina
- Nashville, Tennessee
- San Antonio, Texas
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 23, 2026 · Source of record for eligibility and locations