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

A Phase 1 Dose Escalation and Expansion Open-label, Multicenter, Study of OP-1250 in Combination With the CDK4/6 Inhibitor Palbociclib in Adult Subjects With Advanced or Metastatic HR-positive, HER2-negative Breast Cancer

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).

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: OP-1250; Drug: Palbociclib

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: General Contact Info; Phone Number: 415-651-7206; Email: clinical@olema.com

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Not yet recruiting
      • Site 6104
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Site 6102
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Site 6101
    • Geelong, Victoria, Australia, 3220
      • Recruiting
      • Site 6103
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Site 6105

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation; 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	Drug: OP-1250; Complete Estrogen Receptor Antagonist; Drug: Palbociclib; Palbociclib is an approved CDK 4/6 Inhibitor drug; Other Names: Ibrance®️
Experimental: Dose Expansion; 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	Drug: OP-1250; Complete Estrogen Receptor Antagonist; Drug: Palbociclib; Palbociclib is an approved CDK 4/6 Inhibitor drug; Other Names: Ibrance®️

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Dose Limiting Toxicities	From Cycle 1 Day 1 through C1 Day 28
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

Collaborators and Investigators

• Sponsor: Olema Pharmaceuticals, Inc.
• Collaborators: Pfizer
• Investigators: Study Director: Sue Johnson, Olema Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Palbociclib
• Other Study ID Numbers: OP-1250-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes