MedPath

A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

Phase 1
Active, not recruiting
Conditions
Breast Cancer
Interventions
Drug: Palazestrant
Drug: Palbociclib
Registration Number
NCT05266105
Lead Sponsor
Olema Pharmaceuticals, Inc.
Brief Summary

This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.). Purpose of study is to evaluate the safety and pharmacokinetic (PK) profile, and estimate the preliminary anti-tumor activity of the combination in adult subjects with hormone receptor-positive (ER+ / HER2-) advanced or metastatic breast cancer (MBC).

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Confirmed and evaluable locally advanced or metastatic breast cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Must not have received prior oral endocrine or targeted therapy ≤ 2 weeks prior to first dose
  • Must not have received prior chemotherapy, antibody therapy, or investigational therapy ≤ 4 weeks prior to the first dose
  • Prior radiotherapy must have been completed 2 weeks prior to first dose
  • Adequate safety laboratory tests
  • Willingness to use effective contraception
Read More
Exclusion Criteria
  • Gastrointestinal disease
  • Significant hepatic disease
  • Significant cardiovascular disease
  • Significant ECG abnormalities
  • History of pulmonary embolism or high risk of thrombosis
  • Known HIV infection
  • Active infection (requiring antimicrobial therapy)
  • Pregnant
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Dose EscalationPalazestrantThis portion of the study will evaluate the safety and pharmacology of a range of OP-1250 doses administered daily with Palbociclib in subjects with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer
Dose ExpansionPalazestrantThis portion of the study further explores the clinical activity, safety and pharmacology of OP-1250 in combination with Palbociclib and estimates preliminary data of anti-tumor efficacy
Dose EscalationPalbociclibThis portion of the study will evaluate the safety and pharmacology of a range of OP-1250 doses administered daily with Palbociclib in subjects with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer
Dose ExpansionPalbociclibThis portion of the study further explores the clinical activity, safety and pharmacology of OP-1250 in combination with Palbociclib and estimates preliminary data of anti-tumor efficacy
Primary Outcome Measures
NameTimeMethod
Characterization and Incidence in Adverse Events and Serious Adverse EventsFrom initial inform consent date through 30 days post last dose
Plasma levels of OP-1250 and PalbociclibUp to 9 months
Incidence of Dose Limiting ToxicitiesFrom Cycle 1 Day 1 through C1 Day 28
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (8)

Site 6101

🇦🇺

Clayton, Victoria, Australia

Site 6102

🇦🇺

South Brisbane, Queensland, Australia

Site 6109

🇦🇺

Southport, Queensland, Australia

Site 6104

🇦🇺

Westmead, New South Wales, Australia

Site 6108

🇦🇺

Waratah, New South Wales, Australia

Site 6105

🇦🇺

Nedlands, Western Australia, Australia

Site 6106

🇦🇺

Frankston, Victoria, Australia

Site 6103

🇦🇺

Geelong, Victoria, Australia

© Copyright 2025. All Rights Reserved by MedPath