Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06784193 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Metastatic Breast Cancer and Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC), sponsored by Olema Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
180
Enrollment target
8
Study locations

NCT06784193: Recruiting Phase 1 study of Metastatic Breast Cancer and Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC), sponsored by Olema Pharmaceuticals.

NCT06784193 is a Phase 1 study of Metastatic Breast Cancer and Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) that is actively recruiting participants, run by Olema Pharmaceuticals. The registered enrollment target is 180 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (12% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06784193, a Phase 1 study of Metastatic Breast Cancer and Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC), is actively recruiting participants, sponsored by Olema Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
180 participants
Enrollment target
8
Study locations

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).

Interventions

  • DRUG Fulvestrant
  • DRUG Palazestrant
  • DRUG OP-3136

Study Locations (8)

Florida

  • Florida Cancer Specialists - Sarasota

Louisiana

  • University Medical Center - New Orleans - New Orleans

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Michigan

  • START - Midwest - Grand Rapids

Tennessee

  • SCRI Oncology Partners - Nashville

Texas

  • START - San Antonio - San Antonio

Utah

  • START - Mountain Region - West Valley City

South Australia

  • Cancer Research South Australia - Adelaide

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2024-12-16
Est. Completion 2027-08-30
Phase Phase 1
Olema Pharmaceuticals

5 total trials

What NCT06784193 shows while recruiting

NCT06784193 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (12% lower).

The record links to 6 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Fulvestrant is the first listed.

NCT06784193 lists 8 locations in 8 states (Florida, Louisiana, Massachusetts).

Frequently Asked Questions

What is clinical trial NCT06784193 about?

NCT06784193 is a clinical study titled "Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors". 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 agen...

What is the current status of trial NCT06784193?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2024-12-16. Estimated completion is 2027-08-30.

What conditions does trial NCT06784193 study?

This clinical trial studies the following conditions: Metastatic Breast Cancer, Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC), Advanced or Metastatic ER+ HER2- Breast Cancer (mBC), Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC), Fulvestrant.

What interventions are being tested in trial NCT06784193?

The interventions under investigation include: Fulvestrant (DRUG), Palazestrant (DRUG), OP-3136 (DRUG).

Who is sponsoring clinical trial NCT06784193?

This trial is sponsored by Olema Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06784193 being conducted?

This trial has 8 study locations across Florida, Louisiana, Massachusetts, Michigan, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Metastatic Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06784193's enrollment target sits among peer trials

180 35th of 139 higher than 105 of 139 other Metastatic Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01558804 · 180 participants

    GRoup A StrePtococcus

  • NCT02932176 · 180 participants

    Machine Learning for Handheld Vascular Studies

  • NCT03384563 · 180 participants · Phase 4

    Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane

  • NCT03423628 · 180 participants · Phase 1

    A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT06784193, the US trial registry maintained by the National Library of Medicine. NCT06784193 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.