A Phase 1，Open-label Study of BPI-421286 in Subjects With Advanced Solid Tumors

A Phase 1，Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-421286 in Subjects With Advanced Solid Tumors

Evaluate the safety and tolerability of BPI-421286 in adult subjects with advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with advanced solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cancer; Malignant Neoplasms
• Intervention / Treatment: Drug: BPI-421286

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shun Lu, Ph.D; Phone Number: 13601813062; Email: shun_lu@hotmail.com

Study Locations

• China
  • Shanghai, China, 200030
    • Recruiting
    • Shun Lu, Ph.D
    • Contact: Shun Lu, Ph.D; Phone Number: 13601813062; Email: shun_lu@hotmail.com
    • Principal Investigator: Shun Lu, Ph.D
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shun Lu, Ph.D
      • Contact: Shun Lu, Ph.D; Phone Number: 13601813062; Email: shun_lu@hotmail.com
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Dingzhi Huang, Ph.D
      • Contact: Dingzhi Huang, Ph.D; Phone Number: 18622221232; Email: dingzhi72@163.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Wen Li, Ph.D
      • Contact: 310009 Li, Ph.D; Phone Number: 13958194313; Email: liwenzjhz0408@163.com
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Yun Fan,Ph.D
      • Contact: Yun Fan, Ph.D; Phone Number: 0571-88122092; Email: fanyun@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pathologically documented, locally-advanced or metastatic malignancy
• Standard treatment is not available or patient declines
• Adequate organ function

Exclusion Criteria:

• Active brain metastases from non-brain tumors.
• Gastrointestinal (GI) tract disease causing the inability to take oral medication.
• Other protocol specified criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dose exploration; Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 1-6 subjects treated at the lowest planned dose level. If no DLT is observed, dose escalation will continue to the next planned dose cohort	Drug: BPI-421286; Characterize the pharmacokinetics (PK)，safety，effcicay of BPI-421286 following administration as an oral Tablet formulation
Experimental: dose expansion; dose expansion may proceed with 2 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors. Dose expansion in these 2 groups may be done concurrently	Drug: BPI-421286; Characterize the pharmacokinetics (PK)，safety，effcicay of BPI-421286 following administration as an oral Tablet formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the safety and tolerability of BPI-421286 in subjects with advanced solid tumor malignancies	Number of subjects with treatment related adverse events	20 months
determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen	Number of subjects with dose limiting toxicity	20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the pharmacokinetics of BPI-421286	Blood plasma concentration	20 months
To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-421286	Evaluate clinical activity/efficacy of BPI-421286	20 months
To evaluate the duration of response (DOR) in subjects with CR or PR as best response	Evaluate clinical activity/efficacy of BPI-421286	20 months
to evaluate the disease control rate (DCR)	Evaluate clinical activity/efficacy of BPI-421286	20 months
To evaluate progression-free survival (PFS) following initiation of BPI-421286	Evaluate clinical activity/efficacy of BPI-421286	20 months
To evaluate overall (OS) following initiation of BPI-421286	Evaluate clinical activity/efficacy of BPI-421286	20 months

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2021
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: NSCLC; Pancreatic Cancer; Colorectal Cancer; KRAS G12C; Antineoplastic Agents; KRAS
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: BTP-661311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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