Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HMPL-295S1 · 1 trial · 1 indication
Occurrence of Dose Limiting Toxicities (DLTs) During the DLT Observation Period.
1. Occurrence of Adverse Events (AEs) and Treatment-Related AEs. 2. Number of Participants With Clinical Significant Changes in Vital Signs, Laboratory Parameters and 12-Lead Electrocardiogram (ECG) Findings. 3. Incidence of AEs leading to dose interruption, reduction or permanent discontinuation.
The investigator and the sponsor will determine RP2D jointly based on the following factors: 1. MTD (if reached) 2. PK/pharmacokinetics and relevant efficacy and safety.
| Arm | Type | Description |
|---|---|---|
| HMPL-295S1 open-label treatment arm | EXPERIMENTAL | During dose escalation, single-dose PK evaluation will be carried out firstly in each dose group. At the first therapeutic dose level, the single-dose treatment period is 5 days; from the 2nd dose level, the sponsor can determine the adjustment of single-dose treatment period to 3-5 days based on the available PK profile. Subsequently, the patients will receive oral HMPL-295S1 QD continuously in a therapeutic cycle of 28 days (Day 1 - 28 of each cycle), until reaching the criteria on the end of treatment. The patients in RP2D extended cohort will enter the consecutive treatment period directly. |
| Name | Type | Description |
|---|---|---|
| HMPL-295S1 with dose escalation stage of 5mg up to 200mg, then expansion stage with recommended dose of therapeutic cycle of 28 days . | DRUG | Patient starts the initial dose treatment with 5mg QD of HMPL-295S1, during dose escalation, single-dose PK evaluation will be carried out firstly in each dose group. At the first therapeutic dose level, the single-dose treatment period is 5 days; from the 2nd dose level, the sponsor can determine the adjustment of single-dose treatment period to 3-5 days based on the available PK profile. Subsequently, the patients will receive oral HMPL-295S1 QD continuously in a therapeutic cycle of 28 days (Day 1 - 28 of each cycle), until reaching the criteria on the end of treatment. The patients in RP2D extended cohort will enter the consecutive treatment period directly. |
Inclusion Criteria: All the following conditions must be met for enrollment: 1. Having understood this study adequately and being voluntary to sign the informed consent form; 2. Aged 18\~75 years (inclusive); 3. Patients with histopathologically or cytologically confirmed advanced malignant solid ...
HMPL-295S1 is an investigational small molecule studied in adults with advanced malignant solid tumors. It was evaluated in a Phase 1 trial that included a dose escalation stage from 5 mg up to 200 mg, followed by an expansion stage using the recommended dose on a 28-day therapeutic cycle.
HMPL-295S1 is being developed by HUTCHMED (China) Limited, which trades under the ticker HCM. The company sponsored the Phase 1 study of the compound in patients with advanced malignant solid tumors.
HMPL-295S1 is in Phase 1 development. Its single clinical trial, NCT04908046, has been completed, and the compound remains an investigational agent that has not been established as an approved therapy for advanced malignant solid tumors.
HMPL-295S1 was studied in trial NCT04908046, titled A Study of HMPL-295S1 in Patients With Advanced Malignant Solid Tumors. The Phase 1 trial enrolled 47 patients aged 18 years and older in China and has been completed. It was an uncontrolled study without randomization or double blinding.
The NCT04908046 trial used a dose escalation stage starting at 5 mg and rising to 200 mg, followed by an expansion stage at the recommended dose given over a 28-day therapeutic cycle. It enrolled 47 adults with advanced malignant solid tumors in China and was an open-label, uncontrolled Phase 1 study.