Clinical trial · Interventional
A Study of BPI-452080 in Subjects With Solid Tumors
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-452080 in Subjects With Solid Tumors
NCT05843305CI-TRIAL-00066204unknownPhase 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 open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Von Hippel-Lindau Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BPI-452080 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily.
- interventionNames
- Drug: BPI-452080
- type
- EXPERIMENTAL
- label
- Dose Expansion
- description
- Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily. Cohort 1: Locally Advanced or Metastatic ccRCC Cohort 2: VHL disease associated RCC Cohort 3: Other Advanced Solid Tumors
- interventionNames
- Drug: BPI-452080
Primary outcomes (1)
- measure
- adverse events (AEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed locally advanced or metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists * Dose expansion phase: Arm1:has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen Arm2:Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma Arm3:Other solid tumors * Adequate organ function * Evaluable lesion required for dose escalation phase and at least 1 measurable lesion required for dose expansion phase Exclusion Criteria: * Has received prior treatment with another HIF-2α inhibitor * Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer, etc * Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor * Pregnancy or lactation
References
Publications (0)
Data not yet available
No reference posted for this study.