Testing OP-3136 for advanced solid tumors
A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors
This study is testing a new drug called OP-3136 to see if it can safely help people with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Olema Pharmaceuticals, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Sarasota, Florida and 7 other locations) |
| Trial ID | NCT06784193 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, open-label, multicenter phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OP-3136, a KAT6A/B inhibitor, in patients with advanced or metastatic solid tumors. The study consists of two parts: the first part focuses on dose escalation to determine the maximum tolerated dose, while the second part involves dose expansion to further assess the recommended dose in specific patient cohorts. Participants will receive OP-3136 orally once daily, and the study aims to provide insights into its therapeutic potential for difficult-to-treat cancers.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced or metastatic ER+ HER2- breast cancer, castration-resistant prostate cancer, or non-small cell lung cancer who have limited treatment options.
Not a fit: Patients who have previously received treatment with a KAT6A/B inhibitor or those with symptomatic visceral metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors that are currently difficult to manage.
How similar studies have performed: While this approach is novel in the context of KAT6A/B inhibition, similar studies targeting epigenetic mechanisms have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sarasota, Florida and 7 other locations
- Florida Cancer Specialists — Sarasota, Florida, United States (Recruiting)
- University Medical Center - New Orleans — New Orleans, Louisiana, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- START - Midwest — Grand Rapids, Michigan, United States (Recruiting)
- SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- START - San Antonio — San Antonio, Texas, United States (Recruiting)
- START - Mountain Region — West Valley City, Utah, United States (Recruiting)
- Cancer Research South Australia — Adelaide, South Australia, Australia (Recruiting)
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial Olema Clinical Trial Lead
- Email: clinical@olema.com
- Phone: 415-651-7206
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.