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hmpl-453

Generic: Fanregratinib

hmpl-453: 3 clinical trials tracked.

hmpl-453 evidence translation

What we can confirm

3 tracked trials

No verified listed company relationship

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about hmpl-453, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Study sponsors

No additional listed-company sponsor is linked.

Clinical Trial Registry Records (3)

A Single-center, Open-label, Single-dose Phase I Clinical Study to Investigate the Human Mass Balance in Healthy Chinese Adult Male Subjects Following a Single Oral Dose of 300 mg/200 µCi [14C] HMPL-453

NCT07644442Registry updated 2026-06-12·Phase 1
Completed

Primary endpoint: Human Mass balance

Interventionalopen6 enrolledStarted 2025-02Completion 2025-031 site · ChinaHutchmed

A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HMPL-453 Tartrate as Monotherapy and in Combination With Chemotherapy or Toripalimab in Patients With Advanced Solid Tumors

NCT05173142Registry updated 2026-05-15·Phase 1/Phase 2
Completed

Primary endpoint: Safety and tolerability(Incidence and severity of adverse events (AEs))

Interventionalopen190 enrolledStarted 2022-01Completion 2026-011 site · ChinaHutchison Medipharma Limited

An Open-Label, Single-Arm, Multicenter Phase 2/3b Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-453 Tartrate in Patients With Advanced Intrahepatic Cholangiocarcinoma Habouring FGFR2 Fusion/Rearrangement

NCT04353375Registry updated 2025-12-31·Phase 2/Phase 3
Recruiting

Primary endpoint: Overall response rate (ORR)

Interventionalopen235 targetStarted 2020-09Completion 2030-021 site · ChinaHutchmed