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

Chinese Academy of Medical Sciences1 site in 1 country30 target enrollmentNovember 2018

ConditionsTumor, Solid Lymphoma

InterventionsGR1405 injection

DrugsGR1405 injection

Overview

Phase: Phase 1
Intervention: GR1405 injection
Conditions: Tumor, Solid
Sponsor: Chinese Academy of Medical Sciences
Enrollment: 30
Locations: 1
Primary Endpoint: Maximum tolerated dose (MTD)
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2018

End Date

October 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chinese Academy of Medical Sciences

Responsible Party

Principal Investigator

Shi Yuankai

Vice-president

Chinese Academy of Medical Sciences

Eligibility Criteria

Inclusion Criteria

•Patients with local advanced, recurrent or metastatic solid tumors confirmed by cytology or histology Lymphoma patients with pathological confirmation, and the above pat reients failed to standard treatment failure or had no standard treatment;
•Aged 18 to 75 years men and women;
•At least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors v1.1(RECIST v1.1 )(solid tumor) or Lugano 2014 criteria (lymphoma);
•Eastern Cooperative Oncology Group(ECOG)≤ 1
•Female or male subjects of reproductive age and their mate are willing to take effective contraceptive measures for the entire treatment period and 6 months after the treatment;
•With sufficient organ and bone marrow function;
•At least 4 weeks after the last anti-tumor treatment before the first administration;
•The patient or his legal representative signs a written informed consent.

Exclusion Criteria

•Have experienced any National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) v4.03 or greater than 3 grade irAE during previous immunotherapy treatment;
•Has received any anti-PD-1(programmed death 1) or anti-PD-L1 antibody treatment;
•Subjects with other malignant tumors previously or concurrently ;
•Female patients with pregnancy or lactation;
•Women/men who have fertility refusal to adopt contraception during the trial period;
•Subjects with serious disease or complications, such as gastrointestinal bleeding, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, renal failure, glaucoma, uncontrolled diabetes (CTCAE= 4.03: fasting blood glucose level ≥ 2), and with active infection;
•Had history of acute myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack 6 months before the screening ,grade 2 or above congestive heart failure devised by the New York Heart Association (NYHA);
•Subjects with symptomatic brain metastases or mental disorders;
•Subjects with abnormal levels of serum calcium, magnesium, potassium and have clinical significance;
•Subjects with history of immunodeficiency, including human immunodeficiency virus(HIV)-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;