Clinical trial · Interventional
A Phase 1，Open-label Study of BPI-421286 in Subjects With Advanced Solid Tumors
A Phase 1，Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-421286 in Subjects With Advanced Solid Tumors
NCT05315180CI-TRIAL-00057658unknownPhase 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)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasms | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BPI-421286 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- dose exploration
- description
- Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 1-6 subjects treated at the lowest planned dose level. If no DLT is observed, dose escalation will continue to the next planned dose cohort
- interventionNames
- Drug: BPI-421286
- type
- EXPERIMENTAL
- label
- dose expansion
- description
- dose expansion may proceed with 2 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors. Dose expansion in these 2 groups may be done concurrently
- interventionNames
- Drug: BPI-421286
Primary outcomes (2)
- measure
- Characterize the safety and tolerability of BPI-421286 in subjects with advanced solid tumor malignancies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.