A Phase 1 Study of BPI-28592 in Subjects With Advanced Solid Tumors

A Phase 1，Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ascendind Doses of BPI-28592 in Subjects With Advanced Solid Tumors

This is an open-labe Phase I study of BPI-28592 for the treatment of patients with solid tumors

Study Overview

• Status: Recruiting
• Conditions: Metastasis, Neoplasm
• Intervention / Treatment: Drug: BPI-28592

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hongming Pan, Ph.D; Phone Number: 0571-86006922; Email: shonco@sina.cn

Study Locations

• China
  • Zhejiang
    • HangZhou, Zhejiang, China
      • Recruiting
      • Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
      • Contact: Hongming Pan, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor
• At least 18 years of age
• Measurable or evaluable disease
• Adequate organ function as defined per protocol

Exclusion Criteria:

• Symptomatic or unstable brain metastases
• Pregnancy or lactation
• Other protocol specified criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dose exploration and dose expansion; Patients receive BPI-28592 PO. Cycles repeat every 28 days.	Drug: BPI-28592; Characterize the pharmacokinetics (PK)，safety，antitumor activity of BPI-28592

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the safety and tolerability of BPI-28592 in subjects with advanced solid tumor malignancies	Number of subjects with treatment related adverse events	about 20 months
determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen	Number of subjects with dose limiting toxicity	about 20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the pharmacokinetics of BPI-28592	Blood plasma concentration	about 20 months
To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-28592	Evaluate clinical activity/efficacy of BPI-28592	about 20 months
To evaluate the duration of response (DOR) in subjects with CR or PR as best response	Evaluate clinical activity/efficacy of BPI-28592	about 20 months
to evaluate the disease control rate (DCR)	Evaluate clinical activity/efficacy of BPI-28592	about 20 months
To evaluate progression-free survival (PFS) following initiation of BPI-28592	Evaluate clinical activity/efficacy of BPI-28592	about 20 months
To evaluate overall (OS) following initiation of BPI-28592	Evaluate clinical activity/efficacy of BPI-28592	about 20 months

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: NTRK1/2/3, fusion
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: BTP-661211

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No