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
1 other identifier
interventional
40
1 country
1
Brief Summary
This is an open-labe Phase I study of BPI-28592 for the treatment of patients with solid tumors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2021
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2021
CompletedFirst Submitted
Initial submission to the registry
March 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 31, 2022
March 1, 2022
2.8 years
March 10, 2022
March 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (1)
dose exploration and dose expansion
EXPERIMENTALPatients receive BPI-28592 PO. Cycles repeat every 28 days.
Interventions
Characterize the pharmacokinetics (PK)，safety，antitumor activity of BPI-28592
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Symptomatic or unstable brain metastases
- Pregnancy or lactation
- Other protocol specified criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Related Publications (1)
Sheng J, Chen H, Fu B, Pan H, Wang J, Han W. BPI-28592 as a novel second generation inhibitor for NTRK fusion tumors. NPJ Precis Oncol. 2024 Sep 11;8(1):198. doi: 10.1038/s41698-024-00686-8.
PMID: 39256512DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2022
First Posted
March 31, 2022
Study Start
March 22, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
March 31, 2022
Record last verified: 2022-03