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HMPL-295S1 with dose escalation stage of up to, then expansion stage with recommended dose of therapeutic cycle of 28 days

Phase 1

Advanced Malignant Solid Tumors | Small molecule | Oncology |HUTCHMED (China) Limited|Last Updated: Oct 14, 2024

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment47

FDA Designations

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Clinical trial landscape

HMPL-295S1 with dose escalation stage of up to, then expansion stage with recommended dose of therapeutic cycle of 28 days · 1 trial · 1 indication

Phase 1 1
NCT04908046A Study of HMPL-295S1 in Patients With Advanced Malignant Solid TumorsAdvanced Malignant Solid Tumors
COMPLETED47 Analytics
PHASE1COMPLETED
A Study of HMPL-295S1 in Patients With Advanced Malignant Solid Tumors
Advanced Malignant Solid TumorsUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
HMPL-295S1 with dose escalation stage of 5mg up to 200mg, then expansion stage with recommended dose of therapeutic cycle of 28 days .DRUGPatient 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.
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Frequently asked questions about HMPL-295S1 with dose escalation stage of up to, then expansion stage with recommended dose of therapeutic cycle of 28 days

What is HMPL-295S1 used for?

HMPL-295S1 is an investigational small molecule being studied in adults with advanced malignant solid tumors. It is being developed by HUTCHMED (China) Limited as an oncology therapy. The clinical program has evaluated the drug in a Phase 1 study that has completed enrollment of 47 patients.

Who is developing HMPL-295S1?

HMPL-295S1 is being developed by HUTCHMED (China) Limited, which trades under the ticker HCM. The company is advancing the compound as a small molecule oncology candidate for advanced malignant solid tumors.

What phase is HMPL-295S1 in?

HMPL-295S1 is in Phase 1 clinical development. The single trial for this drug, NCT04908046, has been completed. It was an uncontrolled, non-randomized study that enrolled 47 patients with advanced malignant solid tumors. The drug remains investigational and has not been approved for any indication.

What clinical trials is HMPL-295S1 in?

HMPL-295S1 has been studied in one clinical trial, NCT04908046, titled A Study of HMPL-295S1 in Patients With Advanced Malignant Solid Tumors. This Phase 1 trial enrolled 47 patients and is now completed. It included a dose escalation stage from 5 mg up to 200 mg, followed by an expansion stage at the recommended dose on a 28-day therapeutic cycle.