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Clinical Trials in the UK / NCT06545942
Recruiting Phase 1

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

NCT06545942 · tracked via the Priya Life Science UK tracker
Sponsor
MOMA Therapeutics
Phase
Phase 1
Started
2024-08-13
Last updated
2026-07-23

Condition(s) studied

Advanced Solid TumorMetastatic Solid TumorProstate CancerPancreas CancerBreast CancerOvarian CancerHomologous Recombination Deficiency

Investigational drug(s) / intervention(s)

MOMA-313Olaparib

MOMA-313: MOMA-313 administered orally

Olaparib: Olaparib administered orally

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: 1. Age ≥ 18 years 2. Have histologically confirmed disease for each treatment arm as follows: 1. 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. 2. 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. 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 Key Exclusion Criteria: 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 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

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Investigative Site #108 Goodyear Arizona Recruiting
Investigative Site #101 La Jolla California Recruiting
Investigative Site #111 San Francisco California Completed
Investigative Site #104 Lake Mary Florida Recruiting
Investigative Site #110 St Louis Missouri Recruiting
Investigative Site #103 New York New York Recruiting
Investigative Site #106 New York New York Recruiting
Investigative Site #109 Philadelphia Pennsylvania Recruiting
Investigative Site #107 Myrtle Beach South Carolina Completed
Investigative Site #102 Nashville Tennessee Recruiting
Investigative Site #105 San Antonio Texas Completed
Investigative Site #112 Fairfax Virginia Completed
Investigative Site #114 Barcelona Spain Recruiting
Investigative Site #116 Barcelona Spain Recruiting
Investigative Site #115 Madrid Spain Recruiting
Investigative Site #113 London United Kingdom Recruiting
Investigative Site #117 Manchester United Kingdom Recruiting
Investigative Site #118 Newcastle upon Tyne United Kingdom Recruiting

On this site

📄 Lynparza (olaparib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06545942 on ClinicalTrials.gov ↗ ← All trials in the UK