This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors.
This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors.Enrollment is for patients with advanced adult solid tumors (including but not limited to non-small cell lung cancer, hepatocellular carcinoma, colorectal cancer, cervical cancer, triple-negative breast cancer, gastric cancer/gastroesophageal junction adenocarcinoma, ovarian cancer, pancreatic cancer, bladder cancer, and renal cancer) who have either failed to respond to standard of care or who are unable to receive/do not have access to standard of care.Subjects received HC010 monotherapy by intravenous infusion every two weeks in 1 cycle of 28 days, and were treated until completion of 2 years of study treatment, disease progression, intolerable toxicity, withdrawal of informed consent, loss to follow-up, death, or fulfillment of other criteria for termination of treatment, whichever occurred first. The primary study endpoints were safety and tolerability, maximum tolerated dose (MTD) and/or recommended dose for phase II clinical studies (RP2D); secondary endpoint indicators included pharmacokinetic indicators, efficacy indicators \[objective response rate (ORR), duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)\], immunogenicity indicators such as anti-drug antibody (ADA) and neutralizing antibody (Nab). Exploratory endpoints included the pharmacokinetic (PD) index of HC010, the relationship between peripheral blood T-cell receptor occupancy (RO) and safety and efficacy, as well as the correlation between PD-L1 expression level in tumor tissues and efficacy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
HC010 Q2W/28d intravenous infusion
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGIncidence of dose-limiting toxicity
Incidence of dose-limiting toxicity
Time frame: 28 days
Adverse events
Adverse events
Time frame: 2 years
serious adverse events
serious adverse events
Time frame: 2 years
Maximum Tolerated Dose
Maximum Tolerated Dose
Time frame: 2 years
Recommended Dose for Phase II Clinical Studies
Recommended Dose for Phase II Clinical Studies
Time frame: 2 years
pharmacokinetics:Cmax
pharmacokinetics:Cmax
Time frame: 2 years
Objective response rate
Objective response rate (ORR)
Time frame: 2 years
duration of response
duration of response (DoR)
Time frame: 2 years
progression-free survival
progression-free survival
Time frame: 2 years
overall survival
overall survival
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Time frame: 2 years
Disease control rate
Disease control rate
Time frame: 2 years
pharmacokinetics:AUC0-last
pharmacokinetics:AUC0-last
Time frame: 2 years
pharmacokinetics:tmax
pharmacokinetics:tmax
Time frame: 2 years
pharmacokinetics:Vd
pharmacokinetics:Vd
Time frame: 2 years