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Phase I Clinical Trial in Chinese Patients of Advanced and (or) Recurrent Solid Tumor/Lymphoma

NCT03374007 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-08-16

No results posted yet for this study

Summary

With open, single/ multiple dosing and dose escalation, phase I clinical trial scheme to evaluate safety, tolerance and pharmacokinetic properties of Genolimzumab injection in Chinese patients of advanced and (or) recurrent solid tumor/lymphoma

Conditions

  • Advanced Solid Tumor
  • Recurrent Solid Tumor
  • Lymphoma
  • Recurrent Lymphocyte Depleted Classical Hodgkin Lymphoma

Interventions

BIOLOGICAL

Geptanolimab Injection 1mg/kg

single-dose:1mg/kg

BIOLOGICAL

Geptanolimab Injection 3mg/kg

single-dose: 3mg/kg

BIOLOGICAL

Geptanolimab Injection 10mg/kg

single-dose:10mg/kg

BIOLOGICAL

Geptanolimab Injection 1mg/kg, q2w*6

multiple dosing: 1mg/kg, q2w\*6

BIOLOGICAL

Geptanolimab Injection 3mg/kg, q2w*6

multiple dosing: 3mg/kg, q2w\*6

BIOLOGICAL

Geptanolimab Injection 10mg/kg, , q2w*6

multiple dosing: 10mg/kg, , q2w\*6

BIOLOGICAL

Geptanolimab Injection 280mg, q3w

multiple dosing: 280mg, q3w

BIOLOGICAL

Geptanolimab Injection 3mg/kg, q2w

multiple dosing: 3mg/kg, q2w

Sponsors & Collaborators

  • Genor Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yuankai Shi, Doctor · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-19
Primary Completion
2022-06-30
Completion
2022-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03374007 on ClinicalTrials.gov