RecruitingPhase 1NCT06784193

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

A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors


Sponsor

Olema Pharmaceuticals, Inc.

Enrollment

180 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 safety study of a new experimental drug called OP-3136 for people with advanced cancers that have spread and are no longer responding to standard treatments. The cancers being studied include hormone receptor-positive breast cancer, advanced prostate cancer, and non-small cell lung cancer. **You may be eligible if...** - You have advanced or metastatic ER-positive, HER2-negative breast cancer, prostate cancer (mCRPC), or non-small cell lung cancer - Your cancer is no longer responding to available treatments or those treatments are not tolerable - You are well enough to participate in a clinical trial **You may NOT be eligible if...** - You have a different type of cancer not listed above - Your cancer has not yet progressed on standard therapies - You have significant health conditions that prevent trial participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOP-3136

Selective inhibitor of HAT enzymes KAT6A and KAT6B

DRUGFulvestrant

Selective estrogen receptor degrader (SERD)

DRUGPalazestrant

Complete estrogen receptor antagonist (CERAN)


Locations(8)

Florida Cancer Specialists

Sarasota, Florida, United States

University Medical Center - New Orleans

New Orleans, Louisiana, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

START - Midwest

Grand Rapids, Michigan, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

START - San Antonio

San Antonio, Texas, United States

START - Mountain Region

West Valley City, Utah, United States

Cancer Research South Australia

Adelaide, South Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT06784193


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