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HMPL-A251

Phase 2

Solid Tumors, Adult | Small molecule | Oncology |HUTCHMED (China) Limited|Last Updated: Dec 28, 2025

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
UNCONTROLLED
Total Trials1
Total Enrollment147
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07228247A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid TumorsPHASE1/PHASE2 RECRUITING 147Dec 1, 2025Dec 1, 2028Dec 28, 2025 -
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Study Design & Arms
Interventions
NameTypeDescription
HMPL-A251DRUGSix dose cohorts are planned for the Dose Escalation phase; at least three participants with solid tumors will be enrolled in each dose cohort. Bayesian optimal interval design with backfill (BF-BOIN, Zhao, 2023) will be used to guide dose escalation and determine the MTD and/or RDE of HMPL-A251. All study participants will receive HMPL-A251 as IV infusion until PD, intolerable toxicity, or other protocol-specified criteria for ending study treatment, whichever occurs first.
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07228247studyFirstPostDate: changed