A Phase I Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors
Study Identifier:
MOMA-313-001
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruitment Complete
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Study 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.
To assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-313.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
Female & Male
Age
18 - 64 Years
Study Drug
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Study Status
Indicates the current recruitment status or the expanded access status
Recruitment Complete
Requirements information
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 Participants are eligible for monotherapy if they are previously exposed to PARP inhibitors whereas either naïve or exposed to PARP inhibitors are eligible for combination therapy. Participants must be ≥18 years old, have histologically confirmed advanced or metastatic solid tumors, have evaluable disease defined by measurable or non-measurable lesion(s) using Response Evaluation Criteria in Solid Tumors (RECIST) and/or Prostate Cancer Working Group (PCWG) guidelines, have Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2, and be fully recovered from the effects of prior therapy.
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/L
- 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
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Amita Patnaik
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Prostate
Pancreas
Breast Cancers
Ovarian
Gene Mutations
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Victor Moreno Garcia
Status
Recruitment on Hold
Condition(s) Treated at Site
Solid Tumor
Prostate
Pancreas
Breast Cancers
Ovarian
Gene Mutations
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Neal Shore
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Prostate
Pancreas
Breast Cancers
Ovarian
Gene Mutations