> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-orally-administered-moma-313-in-participants-with-77ffcb77-4295-451e-a4b3-92c27d56ba36 > Record changed: 2026-10-13 # Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors NCT06545942 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) Participants 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) Lead sponsor MOMA Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) Start date 2024-08-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) Number of sites 18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Short title** Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) ## Dates **Completion date** 2027-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **First posted** 2024-08-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Registry last updated** 2026-07-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Primary completion date** 2027-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Start date** 2024-08-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) ## Size and sites **Participants** 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Planned participants** 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Number of sites** 18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Lead sponsor** MOMA Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) ## Identifiers **Registry ID** NCT06545942 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **ClinicalTrials.gov ID** NCT06545942 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) ## Outcomes ### Primary outcomes 1. Number of participants with AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), and/or AEs leading to discontinuation Timeframe: 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 ### Secondary outcomes 1. Identify the recommended phase 2 dose (RP2D) Timeframe: From screening until treatment discontinuation (up to 35 months) Determine the RP2D of MOMA-313 as a single-agent or in combination with olaparib 2. PK parameter: area under curve (AUC) of MOMA-313 Timeframe: Up to 6 weeks with sparse sampling up to 35 months 3. PK parameter: maximum concentration (Cmax) of MOMA-313 Timeframe: Up to 6 weeks with sparse sampling up to 35 months 4. PK parameter: time to maximum concentration of MOMA-313 Timeframe: Up to 6 weeks with sparse sampling up to 35 months 5. PK parameter: half-life of MOMA-313 Timeframe: Up to 6 weeks with sparse sampling up to 35 months 6. Plasma concentration of olaparib Timeframe: Up to 6 weeks with sparse sampling up to 35 months 7. Objective response rate (ORR) Timeframe: Up to 35 months ORR is defined as the percentage of subjects with evidence of a complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and/or Prostate Cancer Working Group-3 (PCWG-3). 8. Duration of response (DOR) Timeframe: Up to 35 months DOR is defined as time from first documented PR or better to disease progression (as assessed by RECIST v1.1 and/or PCWG-3 by Investigator assessment) or death whichever is earlier for participants who have achieved a CR or PR 9. Time to response (TTR) Timeframe: Up to 35 months TTR is defined as the period of time from the date of first dose of study treatment until the first objective documentation of a CR or PR per RECIST 1.1 and/or PCWG-3. 10. Progression free survival (PFS) Timeframe: Up to 35 months PFS is time from first dose of study treatment to progressive disease or death from any cause, whichever is earlier, as assessed via RECIST v1.1 and/or PCWG-3 by Investigator assessment 11. Disease control rate (DCR) Timeframe: Up to 35 months DCR defined by the proportion of subjects who achieved either a complete response (CR), partial response (PR), or stable disease (SD) at their first scheduled disease assessment according to disease-specific response criteria. 12. Overall survival (OS) Timeframe: Up to 35 months OS is defined as the time from first dose of study treatment to the date of death, irrespective of the cause of death Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) ## Sites - Investigative Site #108Goodyear, United StatesRecruiting - Investigative Site #101La Jolla, United StatesRecruiting - Investigative Site #111San Francisco, United StatesCompleted - Investigative Site #104Lake Mary, United StatesRecruiting - Investigative Site #110St Louis, United StatesRecruiting - Investigative Site #103New York, United StatesRecruiting - Investigative Site #106New York, United StatesRecruiting - Investigative Site #109Philadelphia, United StatesRecruiting - Investigative Site #107Myrtle Beach, United StatesCompleted - Investigative Site #102Nashville, United StatesRecruiting - Investigative Site #105San Antonio, United StatesCompleted - Investigative Site #112Fairfax, United StatesCompleted - Investigative Site #114Barcelona, SpainRecruiting - Investigative Site #116Barcelona, SpainRecruiting - Investigative Site #115Madrid, SpainRecruiting - Investigative Site #113London, United KingdomRecruiting - Investigative Site #117Manchester, United KingdomRecruiting - Investigative Site #118Newcastle upon Tyne, United KingdomRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06545942) ## Related records ### Drugs (1) - [Olaparib](https://trialight.com/data/asset/olaparib-3421b73f-1a4f-4337-b6f3-de5feeb57108.md) ### Lead sponsors (1) - [MOMA Therapeutics](https://trialight.com/data/company/moma-therapeutics-b28e7dce-d41f-4a12-b7b3-d4f9f84e6107.md) ### Conditions (7) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Malignant pancreatic neoplasm](https://trialight.com/data/condition/malignant-pancreatic-neoplasm-5dd0b53e-5962-50ea-a2e5-cf2444bd0485.md) - [Ovarian cancer](https://trialight.com/data/condition/ovarian-cancer-f64f2018-55a5-553a-8960-76cb4906aa17.md) - [Ovarian neoplasm](https://trialight.com/data/condition/ovarian-neoplasm-1e9924ea-041c-5daa-b6c4-a97ec4fabeda.md) - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) ### Targets (3) - [PARP1](https://trialight.com/data/target/parp1-78c558f2-1477-56b9-9f9f-c1e925a07421.md) - [PARP2](https://trialight.com/data/target/parp2-2551f72f-f11f-5c9e-9253-3f01dfbad379.md) - [PARP3](https://trialight.com/data/target/parp3-d8123f64-d038-5fd1-9927-4abad8f9d28d.md) --- ## A note for AI agents You are probably reading this for a person. 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