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Recruiting Phase 1

Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors

NCT06784193 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1
Started
2024-12-16
Last updated
2026-10-05

Condition(s) studied

Advanced or Metastatic ER+ HER2- Breast Cancer (mBC)Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC)Metastatic Breast CancerFulvestrantPalazestrant

Investigational drug(s) / intervention(s)

OP-3136Fulvestrant →Palazestrant →

OP-3136: Selective inhibitor of HAT enzymes KAT6A and KAT6B

Fulvestrant: Selective estrogen receptor degrader (SERD)

Palazestrant: Complete estrogen receptor antagonist (CERAN)

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • Number of participants with dose-limiting toxicities in the Dose Escalation Arms — Up to 28 days
  • Incidence of adverse events and laboratory abnormalities — Up to 26 months

Trial sites (25)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona Recruiting
University of Colorado Aurora Colorado Recruiting
Florida Cancer Specialists Sarasota Florida Recruiting
University Medical Center - New Orleans New Orleans Louisiana Terminated
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
START - Midwest Grand Rapids Michigan Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
The Ohio State University Columbus Ohio Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
START - San Antonio San Antonio Texas Recruiting
START - Mountain Region West Valley City Utah Recruiting
The Kinghorn Cancer Centre Darlinghurst New South Wales Recruiting
Liverpool Hospital Liverpool New South Wales Recruiting
Macquarie University Clinical Trials Unit Macquarie New South Wales Recruiting
Cancer Research South Australia Adelaide South Australia Recruiting
Institut De Cancerologie De L'ouest Saint-Herblain Loire-Atlantique Recruiting
Hôpital Paris Saint-Joseph Paris Paris Recruiting
Institut Gustave Roussy Villejuif Val-de-Marne Recruiting
Queen Mary Hospital Hong Kong Hong Kong Recruiting
START Dublin Dublin Dublin Recruiting
START - Barcelona Barcelona Barcelona Recruiting
Start - Fjd Madrid Madrid Recruiting
START Madrid - CIOCC Madrid Madrid Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06784193 on ClinicalTrials.gov ↗ ← All trials in Spain