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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05266105
• Other study ID #: OP-1250-002
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 10, 2021
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: Olema Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Palazestrant
Complete Estrogen Receptor Antagonist
• Palbociclib
Palbociclib is an approved CDK 4/6 Inhibitor drug

Locations

Country	Name	City	State
Australia	Site 6101	Clayton	Victoria
Australia	Site 6106	Frankston	Victoria
Australia	Site 6103	Geelong	Victoria
Australia	Site 6105	Nedlands	Western Australia
Australia	Site 6102	South Brisbane	Queensland
Australia	Site 6109	Southport	Queensland
Australia	Site 6108	Waratah	New South Wales
Australia	Site 6104	Westmead	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Olema Pharmaceuticals, Inc.	Pfizer

Country where clinical trial is conducted

Australia, 

Outcome

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