> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-1-study-of-op-3136-in-advanced-or-metastatic-solid-218c8821-0b8f-4181-bc96-716a49f472d7 > Record changed: 2026-10-29 # Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors NCT06784193 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) Participants 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) Lead sponsor Olema Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) Start date 2024-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) Number of sites 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) ## Title and summary **Summary** This is a first-in-human, open-label, multicenter phase 1 study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, as monotherapy and in combination with other anticancer agents in participants with advanced solid tumors. This study consists of 2 parts: a dose escalation part (Part 1) and dose expansion part (Part 2). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Short title** Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Official title** A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) ## Dates **Completion date** 2027-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **First posted** 2025-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Registry last updated** 2025-10-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Primary completion date** 2027-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Start date** 2024-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) ## Size and sites **Participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Planned participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Number of sites** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Lead sponsor** Olema Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) ## Identifiers **Registry ID** NCT06784193 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **ClinicalTrials.gov ID** NCT06784193 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) ## Outcomes ### Primary outcomes 1. Number of participants with dose-limiting toxicities in the Dose Escalation Arms Timeframe: Up to 28 days 2. Incidence of adverse events and laboratory abnormalities Timeframe: Up to 26 months ### Secondary outcomes 1. Maximum observed concentration (Cmax) Timeframe: Up to 26 months 2. Time to maximum concentration (Tmax) Timeframe: Up to 26 months 3. Area under the curve from time zero to 24 hours (AUC0-24) Timeframe: Up to 26 months 4. Overall Response Rate (ORR) Timeframe: Up to 26 months 5. Duration of Response (DOR) Timeframe: Up to 26 months 6. Clinical Benefit Rate (CBR) Timeframe: Up to 26 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - Participants with advanced or metastatic ER+HER2- breast cancer, mCRPC, or NSCLC (Part 1) or advanced or metastatic ER+HER2- BC or mCRPC (Part 2). - Part 1A (Dose escalation for OP-3136 monotherapy): Participants must have a tumor that is unresectable or metastatic and for which life prolonging measures do not exist or available therapies are intolerable or no longer effective. - Part 1B (Dose escalation for OP-3136 in combination with fulvestrant): Participants with advanced or metastatic ER+ HER2- breast cancer that have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic setting and must have received no more than 2 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting. - Part 1C (Dose escalation for OP-3136 in combination with palazestrant): Participants with advanced or metastatic ER+ HER2- breast cancer that have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic setting and must have received no more than 2 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting. - Part 2A (Dose Expansion in ER+ HER2- mBC for OP-3136 monotherapy): Participants must have received up to 3 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and up to 1 prior line of chemotherapy or an antibody-drug conjugate. - Part 2A (Dose Expansion in mCRPC for OP-3136 monotherapy): Participants must have received up to 4 lines of prior systemic therapy for prostate cancer. Prior therapy must include treatment with an androgen receptor pathway inhibitor(s). - Part 2B (Dose Expansion in ER+ HER2- mBC for OP-3136 in combination with fulvestrant OR Dose Expansion in ER+ HER2- mBC for OP-3136 in combination with palazestrant): Participants must have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic setting. Participants must have received no more than 2 prior lines of endocrine therapy in the advanced or metastatic setting and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting. Key Exclusion Criteria: - Prior therapy with KAT6A/B inhibitor in any treatment setting. - Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term. - Known active or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require CNS-specific treatment, or participants who did not demonstrate clinical and radiologic stability during the last 2 months prior to the first dose of study treatment or require or are currently on steroid therapy for CNS metastases. - History of cerebral vascular disease, including transient ischemic attack, within 6 months prior to the first dose of study treatment. - History of or ongoing impaired cardiac function or clinically significant cardiac disease within 6 months prior to the first dose of study treatment. Note: Additional inclusion/exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) ## Sites - Florida Cancer SpecialistsSarasota, United StatesRecruiting - University Medical Center - New OrleansNew Orleans, United StatesRecruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - START - MidwestGrand Rapids, United StatesRecruiting - SCRI Oncology PartnersNashville, United StatesRecruiting - START - San AntonioSan Antonio, United StatesRecruiting - START - Mountain RegionWest Valley City, United StatesRecruiting - Cancer Research South AustraliaAdelaide, AustraliaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06784193) ## Related records ### Drugs (2) - [Fulvestrant](https://trialight.com/data/asset/fulvestrant-c32705f5-1d97-4fd5-a6ee-76fe1d8eba3a.md) - [Palazestrant](https://trialight.com/data/asset/palazestrant-0fc00556-5838-4030-9ac2-6dbc12179acb.md) ### Lead sponsors (1) - [Olema Pharmaceuticals, Inc.](https://trialight.com/data/company/olema-pharmaceuticals-inc-90a8824d-fd58-45d9-8f36-ddc0bfcb23bf.md) ### Conditions (3) - [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) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) ### Targets (1) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) --- ## A note for AI agents You are probably reading this for a person. 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