Clinical trials / NCT-BPC101-101

phase 1 · Completed

Phase 1 dose escalation and expansion of BPC-101 in HR+ breast cancer

First-in-human dose escalation and expansion study of BPC-101 as monotherapy and in combination with endocrine therapy. Primary objective was safety and recommended Phase 2 dose.

BPC-101 Sample data

Investigational candidate. BPC-101 has not been approved by any regulatory authority.

Enrollment

Patient participation.

Enrolled 48
Target 48
Sites 3

100% of target enrollment reached.

Design

Trial endpoints.

Primary endpoint

Safety, tolerability, and recommended Phase 2 dose.

Secondary endpoints

  • Pharmacokinetics
  • Preliminary antitumor activity by RECIST 1.1

Eligibility

Adults with HR+/HER2- metastatic breast cancer who had progressed on at least one prior endocrine therapy.

Timeline

Started
March 1, 2022
Ended
September 1, 2023

Sites

3 sites for NCT-BPC101-101.

  • Cambridge Research Center

    245 Binney Street, Cambridge, MA 02142

    Cambridge, United States

  • Mass General Cancer Center

    55 Fruit Street, Boston, MA 02114

    Boston, United States

  • Memorial Research Hospital

    1275 York Avenue, New York, NY 10065

    New York, United States
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