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NCT05508906 · ClinicalTrials.gov registry record · Phase 1

Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer

A Phase 1 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Olema Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
190
Enrollment target
16
Study locations

NCT05508906 is a Phase 1 study of Breast Cancer and Metastatic Breast Cancer that is actively recruiting participants, run by Olema Pharmaceuticals. The registered enrollment target is 190 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 16 study locations across 16 states.

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The verdict

NCT05508906, a Phase 1 study of Breast Cancer and Metastatic Breast Cancer, is actively recruiting participants, sponsored by Olema Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
190 participants
Enrollment target
16
Study locations

Study Summary

This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Treatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation). Treatment Group 3: Palazestrant (OP-1250) in combination with everolimus. Treatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.

Conditions Studied

Breast Cancer Metastatic Breast Cancer HER2-Negative Breast Cancer ER Positive Breast Cancer Locally Advanced Breast Cancer

Interventions

  • DRUG Everolimus
  • DRUG Ribociclib
  • DRUG Alpelisib
  • DRUG Palazestrant
  • DRUG Atirmociclib

Study Locations (16)

Arizona

  • Banner MD Anderson Cancer Center - Gilbert

California

  • University of California San Francisco Health - San Francisco

Colorado

  • University of Colorado Cancer Center - Aurora

Florida

  • Advent Health Hematology and Oncology - Orlando

Iowa

  • University of Iowa - Iowa City

Massachusetts

  • Dana Farber Cancer Institute - Boston

Michigan

  • Henry Ford Health - Detroit

Minnesota

  • Regents of the University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 190 participants
Start Date 2022-08-31
Est. Completion 2028-01-31
Phase Phase 1

Sponsor

Olema Pharmaceuticals

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05508906

The ClinicalTrials.gov registry entry for NCT05508906 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The listed sponsor is Olema Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Everolimus is the first listed.

NCT05508906 reports 16 study locations spanning 16 distinct geographic areas - top geographies include Arizona, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT05508906 about?

NCT05508906 is a clinical study titled "Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer". This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Treatment Group 2: Palazestrant (OP-1250) in combination with alpelis...

What is the current status of trial NCT05508906?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 190 participants. The study started on 2022-08-31. Estimated completion is 2028-01-31.

What conditions does trial NCT05508906 study?

This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer, HER2-Negative Breast Cancer, ER Positive Breast Cancer, Locally Advanced Breast Cancer.

What interventions are being tested in trial NCT05508906?

The interventions under investigation include: Everolimus (DRUG), Ribociclib (DRUG), Alpelisib (DRUG), Palazestrant (DRUG), Atirmociclib (DRUG).

Who is sponsoring clinical trial NCT05508906?

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

Where is trial NCT05508906 being conducted?

This trial has 16 study locations across Arizona, California, Colorado, Florida, Iowa. 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.