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

Phase 1UnknownNCT05302843

Betta Pharmaceuticals Co., Ltd.40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastasis, Neoplasm

Interventions

BPI-28592DRUG

Characterize the pharmacokinetics (PK)，safety，antitumor activity of BPI-28592

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Characterize the safety and tolerability of BPI-28592 in subjects with advanced solid tumor malignancies

Number of subjects with treatment related adverse events

Time frame: 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

Time frame: about 20 months

Secondary Outcomes

Evaluate the pharmacokinetics of BPI-28592

Blood plasma concentration

Time frame: 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

Time frame: 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

Time frame: about 20 months

to evaluate the disease control rate (DCR)

Evaluate clinical activity/efficacy of BPI-28592

Time frame: about 20 months

To evaluate progression-free survival (PFS) following initiation of BPI-28592

Evaluate clinical activity/efficacy of BPI-28592

Time frame: about 20 months

To evaluate overall (OS) following initiation of BPI-28592

Central Contacts

Hongming Pan, Ph.D

CONTACT

0571-86006922 shonco@sina.cn

Data from ClinicalTrials.gov

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