Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HMPL-453 · 4 trials · 5 indications
The recovery and cumulative recovery of total radioactivity in excreta (urine and feces).
DLT, TEAEs and SAEs
Objective response rate (ORR) in patients with the selected tumors along with certain FGFR gene alterations
| Arm | Type | Description |
|---|---|---|
| 200µCi [14C] HMPL-453 | EXPERIMENTAL | After an overnight fast of at least 10 hours, subjects will take \[14C\]HMPL-453 (approximately 200 μCi radioactivity) containing 300 mg HMPL-453 30 minutes after starting breakfast (breakfast must be finished within 30 minutes), and ensure that the entire dose is taken within 10 minutes. |
| dose escalation phase of HMPL-453 monotherapy or combination therapy | EXPERIMENTAL | HMPL-453 monotherapy or combination therapy |
| indication specific dose expansion phase of HMPL-453 monotherapy or combination therapy | EXPERIMENTAL | HMPL-453 monotherapy or combination chemotherapy, in patients with IHCC, G/GEJ, UC, and solid tumors harboring specific FGFR gene alterations |
| Name | Type | Description |
|---|---|---|
| HMPL-453 | DRUG | Cohort\_1:HMPL-453 150mg QD continuously in 21-day cycles; Cohort\_2, Cohort\_3 and Cohort\_4:HMPL-453 tartrate 300 mg QD orally (for 14 consecutive days \[Day 1 to 14\], followed by 7 days off \[Day 15 to 21\], 21 days as a treatment cycle) |
| Rabeprazole | DRUG | 20 mg of rabeprazole will be administered by mouth once daily. |
| gemcitabine and cisplatin | DRUG | Gemcitabine and Cisplatin administered intravenously. |
| toripalimab | DRUG | Toripalimab administered intravenously. |
| Docetaxel | DRUG | Docetaxel administered intravenously. |
Inclusion Criteria: 1. The subjects fully understand the content of the experiment, the process and possible adverse reactions, voluntarily sign the informed consent form, can communicate well with the researchers, and can complete all experimental procedures as specified in the protocol; 2. Health...
HMPL-453 is an investigational small molecule being developed for advanced intrahepatic cholangiocarcinoma and other solid tumors. It is currently in Phase 3 clinical development for intrahepatic cholangiocarcinoma, a type of bile duct cancer. The drug is also being studied in earlier phase trials for solid tumors and healthy volunteer studies.
HMPL-453 is a fibroblast growth factor receptor (FGFR) inhibitor, as indicated by its designation as an FGFR inhibitor in clinical trial documentation. It is being evaluated as a monotherapy and in combination with chemotherapy or toripalimab for advanced solid tumors, including intrahepatic cholangiocarcinoma.
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 China and other regions.
HMPL-453 is in Phase 3 clinical development for advanced intrahepatic cholangiocarcinoma. It is an investigational drug and has not been approved by regulatory authorities. The drug is also being studied in Phase 1 trials for solid tumors and healthy volunteer studies.
HMPL-453 has been studied in several clinical trials. NCT05173142 is a Phase Ib/II study evaluating HMPL-453 tartrate as monotherapy and in combination with chemotherapy or toripalimab in advanced solid tumors. NCT05930119 is a food effect and PPI study in healthy volunteers. NCT07644442 is a mass balance study in healthy Chinese adult males, and NCT07697157 studies drug interactions with itraconazole and rifampin.
HMPL-453 and HMPL-453 tartrate refer to the same drug, with tartrate being the salt form used in clinical trials. Clinical trial NCT05173142 evaluates HMPL-453 tartrate, while other studies refer to HMPL-453, indicating they are the same active pharmaceutical ingredient.