Clinical trial · Interventional
HMPL-453 in Advanced Malignant Mesothelioma
A Phase II, Single Arm, Multicenter and Open Labelstudy Evaluating the Efficacy, Safety and Pharmacokinetics of HMPL-453 in Patient With Advanced Malignant Mesothelioma
NCT04290325CI-TRIAL-00045561unknownPhase 2ClinicalTrials.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 a phase II, single arm, multicenter and open-label study to evaluate the efficacy, safety and pharmacokinetic of HMPL-453 in patient with advanced Malignant Mesothelioma
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 |
|---|---|---|---|
| Advanced Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HMPL-453 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HMPL-453
- description
- HMPL-453
- interventionNames
- Drug: HMPL-453
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- measured up to 6 months after the last subject has been enrolled or all subjects have finished their last PFS follow up, whichever comes first
- description
- Evaluating ORR of HMPL-453 in patient with advanced malignant mesothelioma
Secondary outcomes (11)
- measure
- Disease control rate (DCR)
- timeFrame
- measured up to 6 months after the last subject has been enrolled or all subjects have finished their last PFS follow up, whichever comes first
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1.Signed written informed consent; * 2.18 years of age or older; * 3.Histologically diagnosed malignant mesothelioma (including pleura, peritoneum, pericardium, and testicular tendon sheath origin, cell type epithelioid, sarcoma-like, or mixed type), and cannot be cured radically; * 4.Received one to three regimen of prior systemic therapy and then experienced documented radiographic progression or intolerable toxicity; * 5.Patients agreed to provide tumor tissue for FGF/FGFR testing; * 6.Measurable disease by RECIST version 1.1 criteria; * 7.ECOG performance status ≤ 2.; Exclusion Criteria: * 1.Previous treatment with any FGFR inhibitor; * 2.Received systemic anti-cancer therapy within 3 weeks of the first dose of HMPL-453; * 3.Major surgery within 4 weeks of the first dose of HMPL-453; * 4.Use of a strong inducer or inhibitor of cytochrome P450 3A4 (CYP3A4) within 1 week of the first dose of HMPL-453; * 5.Inadequate conditions as indicated by the following laboratory values: * Absolute neutrophil count (ANC)\<1.5 x 109/L * Hemoglobin \< 80 g/L * Platelet count \<80 x 109/L * 6.Any of the following conditions of liver and kidney insufficiency: * Total bilirubin \> 1.5 x ULN * AST and ALT \> 2.5 x ULN (\> 5 x ULN for patients with liver metastases) * Creatinine clearance of \< 50 mL/min as estimated by the Cockcroft-Gault equation * 7.International normalized ratio (INR) \>1.5 or activated partial thromboplastin time (aPTT) \>1.5 x ULN; * 8.Clinical significant liver disease; * 9.Known human immunodeficiency virus (HIV) infection * 10.Previous history of retinal detachment; * 11.Unable to swallow the study drug.
References
Publications (0)
Data not yet available
No reference posted for this study.