Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HMPL-453 with Itraconazole · 1 trial · 1 indication
Area under the plasma concentration - time curve from time 0 to time of last measurable concentration
Area under the plasma concentration - time curve from time 0 extrapolated to infinity
Peak concentration
| Arm | Type | Description |
|---|---|---|
| Part A:HMPL-453 with Itraconazole | OTHER | - |
| Part B:HMPL-453 with Rifampin | OTHER | - |
| Name | Type | Description |
|---|---|---|
| HMPL-453 with Itraconazole | DRUG | HMPL-453: 100mg, D1、D14; Itraconazole: 400mg, D10;200mg,D11-D22 |
| HMPL-453 with Rifampin | DRUG | HMPL-453: 300mg, D1、D16; Rifampin: 600mg, D10-D24 |
Inclusion Criteria: 1. Has fully understood and voluntarily signed the ICF for this study. 2. Male or female 18 years of age or older. 3. Body mass index (BMI) at screening: 18 \< BMI ≤ 29.9 kg/m 2 and weight ≥ 50 kg for men and ≥ 45 kg for women. 4. Female subjects of childbearing potential use hi...
HMPL-453 is an investigational small molecule being developed for oncology indications, including advanced intrahepatic cholangiocarcinoma and solid tumors. It is currently in Phase 3 clinical development for advanced intrahepatic cholangiocarcinoma. The drug is not FDA approved and remains in clinical trials.
HMPL-453 is a fibroblast growth factor receptor (FGFR) inhibitor, as indicated by the clinical trial title for the mass balance study. It is being evaluated in advanced intrahepatic cholangiocarcinoma and other solid tumors. The drug is designed to inhibit FGFR signaling pathways involved in tumor growth.
HMPL-453 is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM. The company is conducting clinical trials for this investigational drug in oncology indications, including advanced intrahepatic cholangiocarcinoma.
HMPL-453 is in Phase 3 clinical development for advanced intrahepatic cholangiocarcinoma, based on a Phase 2/3 trial that is currently recruiting. It is also being studied in earlier phase trials for solid tumors. The drug is investigational and has not been approved by regulatory authorities.
HMPL-453 is being studied in several clinical trials. NCT04353375 is a Phase 2/3 trial in advanced intrahepatic cholangiocarcinoma with 235 participants. NCT05173142 is a completed Phase 1b/2 trial in solid tumors. NCT07644442 and NCT07697157 are completed Phase 1 trials in healthy subjects.
HMPL-453 and HMPL-453 tartrate refer to the same drug, with tartrate being the salt form used in clinical trials. Clinical trial titles such as NCT04353375 and NCT05173142 use the name HMPL-453 Tartrate, while other studies refer to it as HMPL-453. Both names denote the same investigational FGFR inhibitor.