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Trial Summary

This Phase 1/2, multicenter, first-in-human, open-label, dose-escalation, dose expansion, and clinical expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX301 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 three parts: phase 1a dose escalation, phase 1b dose expansion, and phase 2 clinical expansion.

Acronym:

HLX301-001

ACTRN/NCT /ethics:

NCT05102214

Scientific title:

A Phase 1/2 Study of HLX301, A Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, in Patients With Locally Advanced or Metastatic Solid Tumors

Sponsor / Cooperative group:

Shanghai Henlius Biotech

Trial & Patient Characteristics

Cancer TypeAll cancers
Trial TypeTreatment
PhasePhase I, Phase II
Age Range18 years and older
SexAll
Tumour Stream -
Cancer StageLocally Advanced, Metastatic or Widespread
Anticipated Start Date2022-05-03
Anticipated End Date2024-02-01

Participating Hospitals

HospitalSouthern Oncology Clinical Research Unit
Clinical Trial CoordinatorMeggan O'Riley
EmailMeggan.ORiley@socru.org.au
Phone0491 679 039
Principal InvestigatorDr Ganessan Kichenadasse
Recruitment StatusRecruiting