Recent Updates
Recently added Catalysts

HMPL-415S1

Phase 1

Advanced Malignant Solid Tumors | Small molecule | Oncology |HUTCHMED (China) Limited|Last Updated: Jul 21, 2023

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment81

FDA Designations

No designations recorded

Clinical trial landscape

HMPL-415S1 · 1 trial · 1 indication

Phase 1 1
NCT05886374A Study of HMPL-415S1 in Patients With Advanced Malignant Solid TumorsAdvanced Malignant Solid Tumors
RECRUITING81 Analytics
PHASE1RECRUITING
A Study of HMPL-415S1 in Patients With Advanced Malignant Solid Tumors
Advanced Malignant Solid Tumors
NCT0588637481
Unlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or RP2D of HMPL-415S1 as a single oral agent in advanced malignant solid tumor
from Cycle 0Day1 up to Cycle1Day28 (each cycle is 28 days).

Occurrence of Dose Limiting Toxicities (DLTs) During the DLT Observation Period

Secondary Endpoints

To investigate the pharmacokinetic (PK) profile of oral HMPL-415S1
from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).
AUCinf (Cycle 0 ) of HMPL-415S1
from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).
AUC(0-tlast) (Cycle 0 ) of HMPL-415S1
from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HMPL-415S1EXPERIMENTALHMPL-415S1 will be administered orally once daily in 28 days treatment cycles

Interventions

NameTypeDescription
HMPL-415S1DRUGHMPL-415S1 will be supplied as 0.5 mg, 5 mg and 25 mg capsules
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: All the following conditions must be met for enrollment: 1. Fully understand this study and voluntarily sign the ICF; 2. Dose escalation Patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or ...

Countries:China
Unlock Eligibility Criteria

Frequently asked questions about HMPL-415S1

What is HMPL-415S1 used for?

HMPL-415S1 is an investigational small molecule being developed for the treatment of advanced malignant solid tumors. It is currently in Phase 1 clinical development, and the ongoing trial is enrolling patients with advanced malignant solid tumors in China.

Who makes HMPL-415S1?

HMPL-415S1 is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM. The company is conducting a Phase 1 clinical trial of HMPL-415S1 in patients with advanced malignant solid tumors.

What phase is HMPL-415S1 in?

HMPL-415S1 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A Phase 1 trial is currently recruiting participants with advanced malignant solid tumors to evaluate the drug's safety and tolerability.

What clinical trials is HMPL-415S1 in?

HMPL-415S1 is being studied in one active clinical trial, identified as NCT05886374. This Phase 1 study is titled 'A Study of HMPL-415S1 in Patients With Advanced Malignant Solid Tumors' and is recruiting 81 participants aged 18 years and older in China.

Is HMPL-415S1 the same as HMPL-415?

HMPL-415S1 is a distinct drug candidate from HMPL-415. While both are small molecules developed by HUTCHMED, HMPL-415S1 is specifically being studied in a Phase 1 trial for advanced malignant solid tumors, and no alternative names have been reported for this compound.