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A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04505826
Recruitment Status : Active, not recruiting
First Posted : August 10, 2020
Last Update Posted : August 22, 2023
Sponsor:
Information provided by (Responsible Party):
Olema Pharmaceuticals, Inc.

Study Description
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Brief Summary:
This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor (HR)-positive, her2-negative breast cancer.

Condition or disease Intervention/treatment Phase
Hormone Receptor Positive Breast Carcinoma HER2-negative Breast Cancer Drug: OP-1250 Phase 1 Phase 2

Detailed Description:
This is a Phase I dose escalation and dose expansion and Phase II monotherapy open--label, first--in--human study to determine the dose limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), to characterize the safety and pharmacokinetic (PK) profile, and to estimate the preliminary anti-tumor activity of OP-1250 as a single agent in adult subjects with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic or locally advanced breast cancer. This study comprises 2 Phases: Phase I (Part A [Dose Escalation] and Part B [Dose Expansion]) and Phase II. Additionally, all subjects (Phase I and Phase II) will be eligible to participate in 1 of 2 sub-studies. Patients must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease. Patients will be evaluated for treatment emergent adverse events (AEs) during study participation, and toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects With Advanced and/or Metastatic Hormone Receptor (HR)-Positive, HER2-negative Breast Cancer
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: OP-1250 Phase I Part A (Dose Escalation) and Part B (Dose Expansion)
Phase I Part A will evaluate the safety and pharmacokinetics (PK)of a range of OP-1250 doses to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Phase I Part B will evaluate the safety and PK of OP-1250 to confirm the RP2D dose.
 Drug: OP-1250
Complete Estrogen Receptor ANtagonist (CERAN)
Experimental: OP-1250 Phase II

This portion of the study further explores the clinical activity, safety, and PK of OP-1250 monotherapy at the RP2D and will estimate preliminary anti-tumor efficacy in 3 cohorts.

Cohort A will enroll subjects with measurable disease without evidence of CNS metastases; Cohort B will enroll subjects with non-measurable (evaluable) disease without evidence of CNS metastases; and Cohort C will enroll subjects with evaluable disease (measurable and non-measurable) with CNS metastases.

 Drug: OP-1250
Complete Estrogen Receptor ANtagonist (CERAN)


Outcome Measures
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Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLT) [ Time Frame: The first 28 days of treatment ]
    To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of OP-1250, the incidence of DLTs will be assessed.

  2. Characterize the incidence, nature and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of OP-1250 [ Time Frame: Up to 42 days after end of treatment ]
    Characterize the incidence, nature and severity of TEAEs and SAEs of OP-1250 according to NCI-CTCAE version 5.0

  3. Pharmacokinetics of OP-1250 [ Time Frame: Every 28 days ]
    Plasma concentrations of OP-1250 will be assessed at predefined intervals

  4. Anti-tumor activity of OP-1250 [ Time Frame: Every 8 weeks ]
    Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines


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

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease
  • Must not have received prior oral endocrine therapy < 2 weeks prior to first dose
  • Must not have received prior, chemotherapy in 2 weeks or within 5 half-lives whichever is earlier, antibody therapy within 4 weeks or investigational therapy within 4 weeks or 5 half-lives whichever is earlier, prior to the first dose
  • Adequate hepatic function
  • Adequate renal function
  • Normal coagulation panel
  • Willingness to use effective contraception

Exclusion Criteria:

  • Gastrointestinal disease
  • Significant renal disease
  • Significant cardiovascular disease
  • Significant ECG abnormalities
  • Ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial therapy)
  • Pregnancy or breastfeeding
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04505826


Locations
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Sponsors and Collaborators
Olema Pharmaceuticals, Inc.
Investigators
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Study Director: Mark Shilkrut, MD Olema Pharmaceuticals, Inc.
Study Director: Gurpreet Mathauda-Sahota, PharmD Olema Pharmaceuticals, Inc.
More Information
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Responsible Party: Olema Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04505826    
Other Study ID Numbers: OP-1250-001
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: August 22, 2023
Last Verified: August 2023
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases