Phase 1 Study of OP-3136 for Advanced Solid Tumors
This study is testing a new drug called OP-3136, which works by targeting specific enzymes (KAT6A and KAT6B) in cancer cells. It's being studied alone and in combination with other approved cancer medicines like Fulvestrant and Palazestrant. The main goal is to see how safe OP-3136 is and what side effects it might cause, as well as to find the best dose. Researchers will also look at how the drug moves through your body and if it shows any early signs of helping to treat advanced or metastatic (spread to other parts of the body) ER+ HER2- breast cancer, castration-resistant prostate cancer, or non-small cell lung cancer. You may be eligible if you have one of these cancers and are at least 18 years old.
- Study design
- This is an early-stage (Phase 1), open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll about 180 participants to evaluate the new drug.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects for up to 26 months after you start treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06784193
Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentOlema Pharmaceuticals, Inc.
~180 participants
Updated 2025-10-10 on ClinicalTrials.gov
What's tested:OP-3136FulvestrantPalazestrant
At a glance
Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with dose-limiting toxicities in the Dose Escalation Arms
Measured over Up to 28 days
+1 more outcome measured
Conditions
Where it's being run
8 sites across 8 statesFlorida1
Louisiana1
Massachusetts1
Michigan1
Tennessee1
Texas1
Utah1
South Australia1
Who to contact
There may be multiple sites in this clinical trial Olema Clinical Trial Lead
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Exclusion
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.
What this trial measures
- Number of participants with dose-limiting toxicities in the Dose Escalation ArmsUp to 28 days
- Incidence of adverse events and laboratory abnormalitiesUp to 26 months