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Taking people in IrelandPhase 1

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.

Key facts

Who runs it
Olema Pharmaceuticals, Inc.
Where
Dublin, IrelandSee the siteAlso in 5 other countries, 24 sites
Trial code
Registry title
Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
Status
Recruiting
Phase
Phase 1
People taking part
180 people, planned
Started
16 Dec 2024
Expected to end
30 Aug 2027
Type of study
Interventional, 7 groups
Treatments tested
  • OP-3136
  • Fulvestrant
  • Palazestrant
Record updated
5 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Ireland

Also in 5 other countries, 24 sites

  • START DublinDublin, IrelandContact: There may be multiple sites in this clinical trial Olema Clinical Trial LeadTaking people

About the trial

What the trial wants to find out

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

This study consists of 2 parts: a dose escalation part (Part 1) and dose expansion part (Part 2).

The 7 groups in the trial

  • Part 1A Dose Escalation monotherapyTreatment being tested

    Treatment: OP-3136

  • Part 1B Dose Escalation in combination with fulvestrantTreatment being tested

    Treatment: OP-3136 and Fulvestrant

  • Part 1C Dose Escalation in combination with palazestrantTreatment being tested

    Treatment: OP-3136 and Palazestrant

  • Part 2A Dose Expansion monotherapy - mBCTreatment being tested

    Treatment: OP-3136

  • Part 2A Dose Expansion monotherapy - mCRPCTreatment being tested

    Treatment: OP-3136

  • Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1Treatment being tested

    Treatment: OP-3136, Fulvestrant, and Palazestrant

  • Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2Treatment being tested

    Treatment: OP-3136, Fulvestrant, and Palazestrant

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors
Plain-language title
Tests OP-3136 alone and with other drugs in advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
5 October 2026