Tests OP-3136 alone and with other drugs in advanced solid tumors
Tests OP-3136, alone or combined, in adults with advanced or spreading solid cancers.
Plain-language title generated from the registry record
Registry title: Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
Key facts
- Where
- Adelaide, Darlinghurst, Liverpool, and Macquarie, AustraliaSee the 4 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic ER+ HER2- breast cancer, castration-resistant prostate cancer (mCRPC) or non-small cell lung cancer (NSCLC). It tests a new drug, OP-3136, alone or with fulvestrant or palazestrant.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced or metastatic ER+ HER2- breast cancer, mCRPC, or NSCLC (lung cancer only in dose escalation Part 1). The tumor cannot be removed by surgery or has spread.
- Earlier treatment
- Breast cancer: progressed after at least 1 prior line of treatment that included endocrine therapy and a CDK 4/6 inhibitor, with no more than 2 prior lines of endocrine therapy and no more than 1 prior line of chemotherapy or an antibody-drug conjugate (up to 3 prior lines of endocrine therapy in Part 2A monotherapy). Prostate cancer in Part 2A: up to 4 prior lines of systemic therapy, including an androgen receptor pathway inhibitor.
- Biomarker or test result
- ER+ HER2- breast cancer is required for the breast cancer groups.
Main reasons for not taking part
- Earlier treatment with a KAT6A/B inhibitor
- Advanced symptomatic spread to organs, with a short-term risk of life-threatening complications
- Active or symptomatic spread to the central nervous system needing specific treatment
- Stroke or transient ischemic attack within 6 months before the first dose
- Heart problems within 6 months before the first dose
Read by machine on 9 November 2026.
Where in Australia
- Cancer Research South AustraliaAdelaide, AustraliaTaking people
- The Kinghorn Cancer CentreDarlinghurst, AustraliaTaking people
- Liverpool HospitalLiverpool, AustraliaTaking people
- Macquarie University Clinical Trials UnitMacquarie, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Olema Pharmaceuticals, Inc.
- Trial code
- NCT06784193
- Record updated
- 5 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors
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).
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; 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; Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term.