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Clinical trial

A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Phesgo® Biosimilar HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer

NCT07601620 is registered in ClinicalTrials.gov with Shanghai Henlius Biotech as lead sponsor.

NCT NCT07601620
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Registry record

As filed in ClinicalTrials.gov.

Title
A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Phesgo® Biosimilar HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
Lead sponsor
Shanghai Henlius Biotech
Phase
Phase 1
Overall status
Not yet recruiting
Start date
July 3, 2026
Completion date
July 22, 2027
Enrollment
258 (estimated)
Sites
Not reported

Conditions

As the registry lists them; a condition with its own page is linked.

her2 + breast cancer