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drugset / Trial / NCT05360381

HLX35(EGFR×4-1BB Bispecific) in Patients With Advanced or Metastatic Solid Tumors

NCT05360381 ↗

Phase 1 Unknown 82 enrolled Shanghai Henlius Biotech
Non-randomizedSequentialOpen-labelTreatment

Summary

This Phase1, multicenter, first-in-human, open-label, dose-escalation, and dose expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX35 administered as a single-agent by IV infusion every 2 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. This study has two parts: phase 1a dose escalation and phase 1b dose expansion.

Timeline

Start
2022-06-03
Primary completion
2024-10-30
Completion
2024-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX35 Unknown 0.015 mg/kg Intravenous
Subject HLX35 Unknown 0.05 mg/kg Intravenous
Subject HLX35 Unknown 0.1 mg/kg Intravenous
Subject HLX35 Unknown 0.3 mg/kg Intravenous
Subject HLX35 Unknown 1 mg/kg Intravenous
Subject HLX35 Unknown 3 mg/kg Intravenous
Subject HLX35 Unknown 10 mg/kg Intravenous

Indications

non-small cell squamous lung carcinoma