This study is a prospective, single-arm, open-label, dose-escalation study. A total of 4 dose groups were pre-defined in this study. The drug was administered once every 6 weeks.The drug would be administered for 1 to 4 cycles. The dosing schedule and dose could also be adjusted according to the patient's condition. After each dose group completed the enrollment and DLT observation, based on the participant's safety tolerance, radiation dosimetry, and preliminary efficacy evaluation results, it was decided whether to adjust the dose of the subsequent dose groups or to suspend the dose escalation.
Aged 18 to 75 years old male and female.
Patients with advanced malignant solid tumors who have failed standard treatments.
According to RECIST 1.1, there is at least one measurable lesion.
ECOG performance status 0-1.
Received anti-tumor therapy within 4 weeks before enrollment.
Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
Have undergone surgery within 4 weeks before enrollment.
Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).
Single group
INN805
DrugThe drug was administered once every 6 weeks. It was expected that the drug would be administered for 1 to 4 cycles.
Determine dose-limiting toxicity (DLT)
Determine the DLT of INN805
Frequency of adverse events (AEs) and SAEs
To investigate the safety characteristics of INN805
Determine the Maximum Tolerated Dose (MTD)
Determine the MTD of INN805
Objective response rate (ORR)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1
Disease control rate (DCR)
DCR as assessed using RECIST 1.1
Progression free survival (PFS)
PFS as assessed using RECIST 1.1
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FindCure Biosciences (ZhongShan) Co., Ltd.
Lead sponsor
Affiliated Hospital of Jiangnan University
Collaborator
