NCT03313219

Pharmacokinetics and Tolerabilitynce Studies of Gentuximab (Recombinant Anti-VEGFR2 Human-mouse Chimeric Monoclonal Antibody) Injection in the Treatment of Late Recurrence of Metastatic Solid Tumors in China: An Open-label，Non-randomised，Uncontrolled，Dose-escalation，Single Center，Pphase Ia Study in Patients With Late Recurrence of Metastatic Solid Tumors in China

Status unknown Phase 1 Last updated 10 December 2017

What this trial tests

Phase 1 trial testing Gentuximab Injection in Solid Tumor in 20 participants. Status unknown.

Timeline

11 October 2017

Primary endpoint
1 December 2019

1 December 2019

Quick facts

Lead sponsor	Changchun GeneScience Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	11 October 2017
Primary completion	1 December 2019
Estimated completion	1 December 2019
Sites	1 location across China

Drugs / interventions tested

• Gentuximab Injection — full drug profile →

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Dose-limiting toxicities (DLT)
  Time frame: Up to 7 weeks
  Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs). A summary of AEs and SAEs considered by the investigator to be drug-related is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of
• Pharmacokinetics: Maximum Concentration (Cmax) in single dose
  Time frame: Cycle 1(day1-day21)& Cycle 2(day 21-day 49): Predose, 15 minute, 3 hours, 6 hours, 12 hours, 24 hours, 48 hours、day 3, day 4, day 7, day 14 after completion of infusion, Cohort 5 only)
• Pharmacokinetics: Cmax in multiple dose
  Time frame: Predose and 15 minutes after completion of Infusion at day 21, day 28, day 42，Predose and 15 minutes, 3 hours, 8 hours, 24 hours, 48 hours, 96 hours after completion of Infusion at day 35，Predose at day 49（the last follow-up）
• Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) in single dose
  Time frame: Cycle 1(day1-day 21)& Cycle 2(day 21-day49): up to day 21（blood collection time are as follows ：Predose, 15 minutes, 3 hours, 6 hours, 12 hours, 24 hours, 48 hours, day 3, day 4, day 7, day 14 after completion of infusion, Cohort 5 only)
• Pharmacokinetics: AUC in multiple dose
  Time frame: From day 21 up to day 49（blood collection time：Predose and 15 minutes after completion of Infusion at day 21, day 28, day 42，Predose and 15 minutes, 3hours, 8hours, 24hours, 48hours, 96hours after completion of Infusion at day 35，Predose at day 49

Sponsor's own description

The primary objective is to evaluate the safety and, tolerabilitytolerance, pharmacokinetices and immunogenicity of escalating single doses and subsequent multiple dose of Gentuximab Injection in patients with late recurrence of metastatic solid tumors and to determine the maximum tolerated dose（MTD） and dose limiting toxicities（DLT）.with single and subsequent multiple intravenous infusion in patients with late recurrence of metastatic solid tumors and to provide a basis for the protocol design of later clinical trials.

The secondary objective is to evaluate the pharmacokinetics, pharmacodynamics and immunogenicity, and tumor response of multiple dose of Gentuximab Injection in patients with late recurrence of metastatic solid tumors.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.