A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
NCT05114759 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2022-10-12
Summary
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in patients with advanced solid tumors.
Conditions
Interventions
- DRUG
-
SHR-A2009
In dose Escalation: SHR-A2009 will be administered intravenously. Six dose levels are preset. In dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage. In indication Expansion: Indications will be selected to evaluate preliminary efficacy.
Sponsors & Collaborators
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-04
- Primary Completion
- 2023-12-30
- Completion
- 2024-12-30
Countries
- China
- Japan
- South Korea
Study Locations
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