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

Study Timeline

• Study Start: 2021-12-10
• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-03-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-06
• Primary Completion: 2025-01
• Study Completion: 2025-07

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	Palazestrant	This 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 Expansion	Palazestrant	This 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 Escalation	Palbociclib	This 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 Expansion	Palbociclib	This 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

Name	Time	Method
Characterization and Incidence in Adverse Events and Serious Adverse Events	From initial inform consent date through 30 days post last dose
Plasma levels of OP-1250 and Palbociclib	Up to 9 months
Incidence of Dose Limiting Toxicities	From Cycle 1 Day 1 through C1 Day 28

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