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New treatment option for Advanced Solid Tumor
Official title Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06545942
What this study is testing
What is MOMA-313?
MOMA-313 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
You likely can't join 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
See the full eligibility 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...
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Goodyear, Arizona, United States
- La Jolla, California, United States
- San Francisco, California, United States
- Lake Mary, Florida, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Barcelona, Spain
- Madrid, Spain
- London, United Kingdom
- Manchester, United Kingdom
- Newcastle upon Tyne, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goodyear, Arizona, United States; La Jolla, California, United States; San Francisco, California, United States; Lake Mary, Florida, United States; St Louis, Missouri, United States; New York, New York, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.