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

RECRUITING Phase 1

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

NCT05508906 · View on ClinicalTrials.gov ↗

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.

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

4 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Olema Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05508906 reports 16 study locations spanning 16 distinct geographic areas — top geographies include Arizona, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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, Locally Advanced Breast Cancer, ER-positive Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05508906?

The interventions under investigation include: Everolimus (DRUG), Ribociclib (DRUG), Alpelisib (DRUG), Palazestrant (DRUG), Atirmociclib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05508906?

This trial is sponsored by Olema Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial