The objective of the study is to evaluate Tolerability, Safety, and primary Efficacy of Gentuximab Injection at different dosage in combination with Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer patients, to ensure adequate treatment dosage for further study. Meanwhile, the study also evaluate Pharmacokinetics of Gentuximab Injection at different dosage in combination with Paclitaxel.
The study includes dose-limiting toxicity (DLT)observing period and randomization period with two cohorts as low-dose group(Gentuximab Injection 8mg/kg+ paclitaxel) and high-dose group(Gentuximab Injection 12mg/kg+ paclitaxel). During the study,the anti-cancer efficacy, safety and anti-drug antibody were evaluated in all patients. DLT observation is only to subjects enrolled in DLT observation period and it lasts one treatment period. PK were doing in part of subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Administered intravenously (IV)
Administered intravenously (IV)
Fujian Tumor Hospital
Fuzhou, Fujian, China
The Sixth Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Dose-limiting toxicities (DLT)
Number of Participants With One or More Drug-Related Adverse Events (AEs) defined as DLT in the protocol
Time frame: Up to 4 Weeks
AEs or SAEs
Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)
Time frame: Baseline through Study Completion, about 24 weeks
Objective response rate(ORR)
Proportion of Participants With CR and PR
Time frame: Up to 6 cycles (28 days for every cycle)
Progression-free survival (PFS)
The time from randomization to the patient tumor progression or death.
Time frame: Up to 6 cycles (28 days for every cycle)
Disease control rate (DCR)
Proportion of Participants With CR, PR and SD
Time frame: Up to 6 cycles (28 days for every cycle)
Time-to-progress (TTP)
The time from randomization to the patient tumor progression.
Time frame: Up to 6 cycles (28 days for every cycle)
Time-to-failure (TTF)
The time from randomization to the patient withdraw from the study.
Time frame: Up to 6 cycles (28 days for every cycle)
Anti-drug antibody
Number of Participants With Anti-drug Antibodies
Time frame: Up to 6 cycles (28 days for every cycle)
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Hangzhou, Zhejiang, China
...and 2 more locations
Pharmacokinetics Cmax
Maximum Concentration (Cmax)
Time frame: Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle)
Area Under the Concentration-Time Curve (AUC)
Time frame: Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle)