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

Olema Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Breast Cancer

Treatments: Drug: Palazestrant; Drug: Palbociclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05266105

OP-1250-002

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Dose Escalation

Experimental group

Description:

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

Treatment:

Drug: Palbociclib

Drug: Palazestrant

Dose Expansion

Experimental group

Description:

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

Treatment:

Drug: Palbociclib

Drug: Palazestrant