GR1405 Injection in Patients With Advanced Solid Tumor or Lymphoma

November 4, 2018 updated by: Shi Yuankai, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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;
  2. Aged 18 to 75 years men and women;
  3. 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);
  4. Eastern Cooperative Oncology Group(ECOG)≤ 1
  5. 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;
  6. With sufficient organ and bone marrow function;
  7. At least 4 weeks after the last anti-tumor treatment before the first administration;
  8. The patient or his legal representative signs a written informed consent.

Exclusion Criteria:

  1. 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;
  2. Has received any anti-PD-1(programmed death 1) or anti-PD-L1 antibody treatment;
  3. Subjects with other malignant tumors previously or concurrently ;
  4. Female patients with pregnancy or lactation;
  5. Women/men who have fertility refusal to adopt contraception during the trial period;
  6. 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;
  7. 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);
  8. Subjects with symptomatic brain metastases or mental disorders;
  9. Subjects with abnormal levels of serum calcium, magnesium, potassium and have clinical significance;
  10. Subjects with history of immunodeficiency, including human immunodeficiency virus(HIV)-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;
  11. Subjects with active hepatitis B (HBsAg and/or HBcAb positive, and HBV DNA titer in peripheral blood was greater than 1 x 103 IU/ml), and/or hepatitis C;
  12. Subjects who have alcohol addiction and/or drug abuse;
  13. Subjects with bleeding or coagulation dysfunction in the past 3 months (Prothrombin time(PT)>1.5×upper limit of normal(ULN); activated partial thromboplastin time(APTT)>1.5×ULN; thrombin time(TT)>1.5×ULN);
  14. Subjects with allergic constitution or allergic to known components of the drug;
  15. Those who received other clinical trial drug therapy within 1 month before the first administration;
  16. Receive a live attenuated vaccine within 4 weeks prior to the first dose of study treatment or during the study period;
  17. Other subjects judged by the investigator to be ineligible for enrollment in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GR1405 injection 3 mg/kg
According to the patient's weight, the dose of this group is 3mg/kg.
Drug: GR1405 injection
Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks.
Other Names:
  • PD-L1 monoclonal antibody
Experimental: GR1405 injection 10 mg/kg
According to the patient's weight, the dose of this group is 10mg/kg.
Drug: GR1405 injection
Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks.
Other Names:
  • PD-L1 monoclonal antibody
Experimental: GR1405 injection 20 mg/kg
According to the patient's weight, the dose of this group is 20mg/kg.
Drug: GR1405 injection
Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks.
Other Names:
  • PD-L1 monoclonal antibody
Experimental: GR1405 injection 30 mg/kg
According to the patient's weight, the dose of this group is 30mg/kg.
Drug: GR1405 injection
Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks.
Other Names:
  • PD-L1 monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose (MTD)
Time Frame: 2 weeks
Maximum tolerated dose of GR1405 injection
2 weeks
Adverse Events
Time Frame: Approximately 3 years
Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v4.03
Approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum concentration (Cmax)
Time Frame: Approximately 2 years
the maximum exposure to a biologically active physica
Approximately 2 years
Duration of response (DOR)
Time Frame: Approximately 3 years
DOR by RECIST v. 1.1 or Lugano 2014, the time between the initial response to therapy and subsequent disease progression or relapse
Approximately 3 years
Objective Response Rate(ORR)
Time Frame: Approximately 3 years
Objective Response Rate(ORR) by RECIST v. 1.1 or Lugano 2014, ORR=complete response(CR) + partial response(PR)
Approximately 3 years
Progression free survival(PFS)
Time Frame: Approximately 3 years
Progression free survival(PFS) by RECIST v. 1.1 or Lugano 2014, a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works
Approximately 3 years
Immunogenicity
Time Frame: Approximately 3 years
the ability to elicit an immune response of GR1405 injection,
Approximately 3 years
Recommended dose for Phase II trial(RP2D)
Time Frame: Approximately 3 years
The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced dose-limiting toxicity(DLT) attributable to the study drug. The MTD will be the RP2D
Approximately 3 years
AUC0-t
Time Frame: Approximately 2 years
Area under the curve in the period from 0 to t
Approximately 2 years
AUC0-∞
Time Frame: Approximately 2 years
Area under the curve in the period from 0 to ∞
Approximately 2 years
AUCss
Time Frame: Approximately 2 years
Area under the curve of Steady-State Plasma Concentrations
Approximately 2 years
T max
Time Frame: Approximately 2 years
the time of occurrence of peak drug concentration
Approximately 2 years
t 1/2
Time Frame: Approximately 2 years
the time of half-life of the drug
Approximately 2 years
apparent volume of distribution (Vz)
Time Frame: Approximately 2 years
the volume of fluid that would be required to contain the amount of drug in the body
Approximately 2 years
clearance(CL)
Time Frame: Approximately 2 years
the rate of elimination of the drug in vivo
Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

November 2, 2018

First Submitted That Met QC Criteria

November 4, 2018

First Posted (Actual)

November 6, 2018

Study Record Updates

Last Update Posted (Actual)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 4, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR1405-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma

Clinical Trials on GR1405 injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe