SOC2006
20 Apr 2022
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 Type | All cancers |
|---|---|
| Trial Type | Treatment |
| Phase | Phase I |
| Age Range | 18 years and older |
| Sex | All |
| Tumour Stream | - |
| Cancer Stage | Locally Recurrent or Locally Advanced; Metastatic or Widespread |
| Anticipated Start Date | 2020-09-03 |
| Anticipated End Date | 2023-12-01 |
Participating Hospitals
| Hospital | Southern Oncology Clinical Research Unit |
|---|---|
| Clinical Trial Coordinator | Meggan O'Riley |
| Meggan.ORiley@socru.org.au | |
| Phone | 0491 679 039 |
| Principal Investigator | Dr Amitesh Roy |
| Recruitment Status | Recruiting |