NCT03731390

GR1405 Injection in Patients With Advanced Solid Tumor or Lymphoma

A Phase I Clinical Study for Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Repeated Doses, Dose Escalation of GR1405 Injection in Patients With Advanced Solid Tumor or Lymphoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I clinical study for evaluating the safety, pharmacokinetics, and preliminary efficacy of repeated doses, dose escalation of GR1405 injection in patients with advanced solid tumor or lymphoma

Detailed description

To evaluate the tolerability, safety, pharmacokinetics, and preliminary efficacy of GR1405 injection monotherapy in an open, non-controlled, escalating trial design in patients with advanced solid tumors or lymphomas. Four dose levels (3 mg/kg, 10 mg/kg, 20 mg/kg, and 30 mg/kg) were evaluated at this stage.

Conditions

• Tumor, Solid
• Lymphoma

Interventions

Type	Name	Description
DRUG	GR1405 injection	Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks.

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-10-01
• Completion: 2021-10-01
• First posted: 2018-11-06
• Last updated: 2018-11-06

Locations

1 site across 1 country: China