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HMPL-415S1

Phase 1

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

HMPL-415S1 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2023

HMPL-415S1 target and mechanism

Molecular targetSHP2
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment81

FDA Designations

No designations recorded

HMPL-415S1 clinical trials

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 TumorsUnlock 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).
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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
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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
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Frequently asked questions about HMPL-415S1

What is HMPL-415S1 used for?

HMPL-415S1 is an investigational small molecule being studied for the treatment of advanced malignant solid tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does HMPL-415S1 target?

HMPL-415S1 targets SHP2, a protein tyrosine phosphatase involved in cell signaling pathways. By inhibiting SHP2, the drug aims to disrupt signaling that can promote tumor growth in advanced solid tumors.

Who is developing HMPL-415S1?

HMPL-415S1 is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM.

What phase is HMPL-415S1 in?

HMPL-415S1 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing trial is recruiting patients with advanced malignant solid tumors in China.

What clinical trials is HMPL-415S1 in?

HMPL-415S1 is being evaluated in a Phase 1 clinical trial with the identifier NCT05886374. This open-label, uncontrolled study is recruiting approximately 81 adult patients with advanced malignant solid tumors in China.

Is HMPL-415S1 the same as SHP2 inhibitors?

HMPL-415S1 is a specific SHP2 inhibitor, meaning it is designed to block the activity of the SHP2 protein. It is one of several investigational drugs in this class, but it is a distinct compound developed by HUTCHMED.