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

Olema Pharmaceuticals, Inc.153 enrolled

Overview

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.

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. 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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

153

Conditions

Hormone Receptor Positive Breast Carcinoma HER2-negative Breast Cancer

Interventions

OP-1250DRUG

Complete Estrogen Receptor ANtagonist (CERAN)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key 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 Key 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

Locations (19)

UCLA Hematology/Oncology

Los Angeles, California, United States

University of Colorado

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Dose Limiting Toxicities (DLT)

Number of Participants with Dose Limiting Toxicities (DLT) during Dose Escalation Only

Time frame: Up to 28 days from start of treatment

Characterize the Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) of OP-1250 That Had at Least One Treatment Emergent Adverse Event

Characterize the incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of OP-1250 in patients that had at least one treatment emergent adverse event according to NCI-CTCAE version 5.0.

Time frame: Up to 3 years, 11 months, and 17 days.

Pharmacokinetics of OP-1250

Plasma concentrations of OP-1250 assessed steady state

Time frame: AUC (0-24) at steady state after 4 weeks of administration

Anti-tumor Activity of OP-1250 (cPR)

Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines (Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR)). Overall response rate which includes confirmed Partial Response (cPR).

Time frame: Imaging studies performed every 8 weeks from date of first dose through cycle 9 then afterwards every 12 weeks until date of first documented disease progression: assessed up to 3 years, 11 months, and 17 days

Data from ClinicalTrials.gov

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