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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 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.
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2024-12-16 |
| Est. Completion | 2027-08-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06784193
The ClinicalTrials.gov registry entry for NCT06784193 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (12% lower). The listed sponsor is Olema Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.
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 reports 8 study locations spanning 8 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.