Clinical trial · Interventional
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
NCT05302843CI-TRIAL-00057437unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-labe Phase I study of BPI-28592 for the treatment of patients with solid tumors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastasis, Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BPI-28592 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- dose exploration and dose expansion
- description
- Patients receive BPI-28592 PO. Cycles repeat every 28 days.
- interventionNames
- Drug: BPI-28592
Primary outcomes (2)
- measure
- Characterize the safety and tolerability of BPI-28592 in subjects with advanced solid tumor malignancies
- timeFrame
- about 20 months
- description
- Number of subjects with treatment related adverse events
- measure
- determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen
- timeFrame
- about 20 months
- description
- Number of subjects with dose limiting toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSheng 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 39256512