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...