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Trial Summary

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.

Acronym:

SOC2006

ACTRN/NCT /ethics:

NCT04446260

Scientific title:

A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subject

Sponsor / Cooperative group:

Jiangsu HengRui Medicine Co.

Trial & Patient Characteristics

Cancer TypeAll cancers
Trial TypeTreatment
PhasePhase I
Age Range18 years and older
SexAll
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced; Metastatic or Widespread
Anticipated Start Date2020-09-03
Anticipated End Date2023-12-01

Participating Hospitals

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