> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-orally-administered-moma-341-in-participants-with-a33dc58f-c44f-48a2-ad80-6d541a8391ec > Record changed: 2026-11-04 # Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors NCT06974110 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) Participants 132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) Lead sponsor MOMA Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) Start date 2025-07-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) Number of sites 15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) ## 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-341 administered orally as a single agent or combination therapy in patients with microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Short title** Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Official title** A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants With Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) ## Dates **Completion date** 2028-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **First posted** 2025-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Registry last updated** 2026-07-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Primary completion date** 2027-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Start date** 2025-07-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) ## Size and sites **Participants** 132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Planned participants** 132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Number of sites** 15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Lead sponsor** MOMA Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) ## Identifiers **Registry ID** NCT06974110 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **ClinicalTrials.gov ID** NCT06974110 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) ## 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-341 given as a single-agent, and in combination with irinotecan, and in combination with immunotherapy ### 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-341 as a single-agent, and in combination with irinotecan, and in combination with immunotherapy 2. PK parameter; area under curve (AUC) of MOMA-341 Timeframe: Up to 6 weeks with sparse sampling up to 35 months Determine the AUC of MOMA-341 as a single-agent, and in combination with irinotecan, and in combination with immunotherapy 3. PK parameter; maximum concentration (Cmax) of MOMA-341 Timeframe: Up to 6 weeks with sparse sampling up to 35 months Determine the Cmax of MOMA-341 as a single-agent, and in combination with irinotecan, and in combination with immunotherapy 4. PK parameter; time to maximum concentration (Tmax) of MOMA-341 Timeframe: Up to 6 weeks with sparse sampling up to 35 months Determine the Tmax of MOMA-341 as a single-agent, and in combination with irinotecan, and in combination with immunotherapy 5. PK parameter; half-life (T1/2) of MOMA-341 Timeframe: Up to 6 weeks with sparse sampling up to 35 months Determine the T1/2 of MOMA-341 as a single-agent, and in combination with irinotecan, and in combination with immunotherapy 6. PK parameter; plasma exposure of irinotecan Timeframe: Up to 6 weeks with sparse sampling up to 35 months Determine the plasma exposure of irinotecan in combination with MOMA-341 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 defined as the time from first dose of study treatment to progressive disease or death from any cause, whichever is earlier, as assessed by RECIST 1.1 and/or PCWG-3 by investigator assessment 11. Disease control rate (DCR) Timeframe: Up to 35 months DCR is defined as the proportion of subjects who achieved either CR, PR, or stable disease (SD) at the 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/NCT06974110) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Age ≥ 18 years 2. Participants have unresectable advanced or metastatic solid tumors with MSI-H or dMMR alterations and histologically confirmed disease. Participants must have previously received and progressed on an anti-PD-(L)1-based regimen, unless ineligible or in a region without access to anti-PD-(L)1 therapies 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 ### Exclusion criteria 1. Known Werner Syndrome 2. Active prior or concurrent advanced-stage malignancy (some exceptions allowed including early-stage cancers) 3. Clinically relevant cardiovascular disease 4. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed) 5. Known active uncontrolled infection 6. Known allergy, hypersensitivity, and/or intolerance to MOMA-341 7. Impaired GI function that may impact absorption 8. Patient is pregnant or breastfeeding 9. 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 10. Active liver disease (some exceptions are allowed) 11. 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/NCT06974110) ## Sites - Investigative Site #132Phoenix, United StatesRecruiting - Investigative Site #101San Diego, United StatesRecruiting - Investigative Site #128Tampa, United StatesRecruiting - Investigative Site #120Detroit, United StatesRecruiting - Investigative Site #110St Louis, United StatesRecruiting - Investigative Site #131Raleigh, United StatesRecruiting - Investigative Site #121Portland, United StatesRecruiting - Investigative Site #127Dallas, United StatesCompleted - Investigative Site #129Houston, United StatesRecruiting - Investigative Site #122Sydney, AustraliaRecruiting - Investigative Site #123Westmead, AustraliaRecruiting - Investigative Site #124Woolloongabba, AustraliaCompleted - Investigative Site #125Adelaide, AustraliaRecruiting - Investigative Site #126Clayton, AustraliaRecruiting - Investigative Site #119Perth, AustraliaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06974110) ## Related records ### Drugs (1) - [Irinotecan](https://trialight.com/data/asset/irinotecan-a601fe30-4b46-4a3b-bf58-6c490646db73.md) ### Lead sponsors (1) - [MOMA Therapeutics](https://trialight.com/data/company/moma-therapeutics-b28e7dce-d41f-4a12-b7b3-d4f9f84e6107.md) ### Conditions (7) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Endometrium neoplasm](https://trialight.com/data/condition/endometrium-neoplasm-26985bd5-b9dd-55b8-9a46-6068daab5c23.md) - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) Primary condition ### Targets (1) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) --- ## A note for AI agents You are probably reading this for a person. 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