A multicenter, open-label, phase I dose escalation study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YH002 in combination with YH001 in subjects with advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
YH002 on CnD1,YH001 on CnD8,Q3W
YH002 and YH001 on same day,Q3W
A traditional 3+3 dose escalation algorithm
Orange Health Services
Orange, New South Wales, Australia
Macquarie University Hospital
Sydney, New South Wales, Australia
Peninsula and South Eastern Haematology & Oncology Group
Frankston, Victoria, Australia
Determined the maximum tolerated dose (MTD)
The safety profile of combination treatment will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0
Time frame: Up to 1 year after the last dosing
Determined the recommended Phase II dose (RP2D)
The safety profile of combination treatment will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0
Time frame: Up to 1 year after the last dosing
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Cabrini Hospital Malvern
Malvern, Victoria, Australia
Henan Tumor Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China