RecruitingPhase 1NCT06545942
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
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
Sponsor
MOMA Therapeutics
Enrollment
220 participants
Start Date
Aug 13, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria13
- 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
Exclusion Criteria15
- 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
Interventions
DRUGMOMA-313
MOMA-313 administered orally
DRUGOlaparib
Olaparib administered orally
Locations(18)
View Full Details on ClinicalTrials.gov
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NCT06545942
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