The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-3802 monotherapy in patients with malignant solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
HRS-3802
GenesisCare North Shore (Oncology)
Saint Leonards, New South Wales, Australia
ACTIVE_NOT_RECRUITINGMacquarie University Hospital
Sydney, New South Wales, Australia
ACTIVE_NOT_RECRUITINGJohn Flynn Private Hospital
Tugun, Queensland, Australia
Number of subjects with adverse events and the severity of adverse events
Time frame: Every 4 weeks after treatment initiation (through study completion,an average 5 mouths)
Dose-limiting toxicity (DLT)
Time frame: During the first 28-day cycle of HRS-3802 treatment
Maximum tolerated dose (MTD)
Time frame: 3 weeks after treatment initiation
Recommended Phase II Dose (RP2D)
Time frame: 3 weeks after treatment initiation
Objective response rate (ORR) - RECIST 1.1
ORR is defined as the proportion of subjects who have achieved complete response (CR) or partial response (PR) according to RECIST 1.1.
Time frame: Up to approximately 6 months
Duration of Response (DoR) per RECIST 1.1
Time frame: Up to approximately 2 years
Progression-free survival (PFS) per RECIST 1.1
Time frame: Up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GenesisCare St Andrews
Adelaide, South Australia, Australia
ACTIVE_NOT_RECRUITINGPeninsula and South Eastern Haematology & Oncology Group
Frankston, Victoria, Australia
ACTIVE_NOT_RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITING