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

NCT05508906 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-10-22

No results posted yet for this 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

Interventions

DRUG

Palazestrant

Complete estrogen receptor antagonist (CERAN)

DRUG

Ribociclib

All subjects in Treatment Group 1 will receive palazestrant in combination with ribociclib.

DRUG

Alpelisib

All subjects in Treatment Group 2 will receive palazestrant in combination with alpelisib.

DRUG

Everolimus

All subjects in Treatment Group 3 will receive palazestrant in combination with everolimus.

DRUG

Atirmociclib

All subjects in Treatment Group 4 will receive palazestrant in combination with atirmociclib.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Olema Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniela Vecchio, PhD · Olema Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2027-12-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT05508906 on ClinicalTrials.gov