MedTrace Logo

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

NCT06784193 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-10-10

No results posted yet for this 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).

Conditions

  • 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 Cancer
  • Fulvestrant
  • Palazestrant

Interventions

DRUG

OP-3136

Selective inhibitor of HAT enzymes KAT6A and KAT6B

DRUG

Fulvestrant

Selective estrogen receptor degrader (SERD)

DRUG

Palazestrant

Complete estrogen receptor antagonist (CERAN)

Sponsors & Collaborators

  • Olema Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2027-05-30
Completion
2027-08-30
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06784193 on ClinicalTrials.gov