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Clinical Trials/NCT05302843
NCT05302843UnknownPhase 1

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

Betta Pharmaceuticals Co., Ltd.1 site in 1 country40 target enrollmentStarted: March 22, 2021Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Enrollment
40
Locations
1
Primary Endpoint
Characterize the safety and tolerability of BPI-28592 in subjects with advanced solid tumor malignancies
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

dose exploration and dose expansion

Experimental

Patients receive BPI-28592 PO. Cycles repeat every 28 days.

Intervention: BPI-28592 (Drug)

Outcomes

Primary Outcomes

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

Time Frame: about 20 months

Number of subjects with treatment related adverse events

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

Time Frame: about 20 months

Number of subjects with dose limiting toxicity

Secondary Outcomes

  • Evaluate the pharmacokinetics of BPI-28592(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(about 20 months)
  • To evaluate the duration of response (DOR) in subjects with CR or PR as best response(about 20 months)
  • to evaluate the disease control rate (DCR)(about 20 months)
  • To evaluate progression-free survival (PFS) following initiation of BPI-28592(about 20 months)
  • To evaluate overall (OS) following initiation of BPI-28592(about 20 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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