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HMPL-415S1

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment81
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05886374A Study of HMPL-415S1 in Patients With Advanced Malignant Solid TumorsPHASE1 RECRUITING 81 — — Jul 6, 2023Jun 30, 2026Jul 21, 20231 China
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05886374primaryCompletionDate: changed
LOWMay 24, 2026NCT05886374studyFirstPostDate: changed