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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05266105
Recruitment Status : Recruiting
First Posted : March 4, 2022
Last Update Posted : March 4, 2022
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: OP-1250 Drug: Palbociclib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 10, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Palbociclib

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 Name: 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 Name: Ibrance®️

Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities [ Time Frame: From Cycle 1 Day 1 through C1 Day 28 ]
  2. Characterization and Incidence in Adverse Events and Serious Adverse Events [ Time Frame: From initial inform consent date through 30 days post last dose ]
  3. Plasma levels of OP-1250 and Palbociclib [ Time Frame: Up to 9 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05266105

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Contact: General Contact Info 415-651-7206

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Australia, New South Wales
Site 6104 Not yet recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Site 6102 Recruiting
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Site 6101 Recruiting
Clayton, Victoria, Australia, 3168
Site 6103 Recruiting
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Site 6105 Recruiting
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Olema Pharmaceuticals, Inc.
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Study Director: Sue Johnson Olema Pharmaceuticals, Inc.
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Responsible Party: Olema Pharmaceuticals, Inc. Identifier: NCT05266105    
Other Study ID Numbers: OP-1250-002
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action