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

Betta Pharmaceuticals Co., Ltd.80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Neoplasms Metastatic Cancer

Interventions

BPI-421286DRUG

Characterize the pharmacokinetics (PK)，safety，effcicay of BPI-421286 following administration as an oral Tablet formulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (5)

Shun Lu, Ph.D

Shanghai, Shanghai Municipality, China

RECRUITING

Dingzhi Huang, Ph.D

Tianjin, Tianjin Municipality, China

RECRUITING

Wen Li, Ph.D

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Characterize the safety and tolerability of BPI-421286 in subjects with advanced solid tumor malignancies

Number of subjects with treatment related adverse events

Time frame: 20 months

determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen

Number of subjects with dose limiting toxicity

Time frame: 20 months

Secondary Outcomes

Evaluate the pharmacokinetics of BPI-421286

Blood plasma concentration

Time frame: 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

Time frame: 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

Time frame: 20 months

to evaluate the disease control rate (DCR)

Evaluate clinical activity/efficacy of BPI-421286

Time frame: 20 months

To evaluate progression-free survival (PFS) following initiation of BPI-421286

Evaluate clinical activity/efficacy of BPI-421286

Time frame: 20 months

To evaluate overall (OS) following initiation of BPI-421286

Central Contacts

Shun Lu, Ph.D

CONTACT

13601813062 shun_lu@hotmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.