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

Sponsor
Olema Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05266105
Collaborator
Pfizer (Industry)
30
Enrollment
5
Locations
2
Arms
23.7
Anticipated Duration (Months)
6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 10, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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®️

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Dose Limiting Toxicities [From Cycle 1 Day 1 through C1 Day 28]

    2. Characterization and Incidence in Adverse Events and Serious Adverse Events [From initial inform consent date through 30 days post last dose]

    3. Plasma levels of OP-1250 and Palbociclib [Up to 9 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 6104 Westmead New South Wales Australia 2145
    2 Site 6102 South Brisbane Queensland Australia 4101
    3 Site 6101 Clayton Victoria Australia 3168
    4 Site 6103 Geelong Victoria Australia 3220
    5 Site 6105 Nedlands Western Australia Australia 6009

    Sponsors and Collaborators

    • Olema Pharmaceuticals, Inc.
    • Pfizer

    Investigators

    • Study Director: Sue Johnson, Olema Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Olema Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT05266105
    Other Study ID Numbers:
    • OP-1250-002
    First Posted:
    Mar 4, 2022
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Breast Neoplasms
    Palbociclib

    Study Results

    No Results Posted as of Mar 4, 2022