GR1405 Injection in Patients With Advanced Solid Tumor or Lymphoma

NCT ID: NCT03731390

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2021-10-31

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.

Conditions

Tumor, Solid; Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GR1405 injection 3 mg/kg

According to the patient's weight, the dose of this group is 3mg/kg.

Group Type: EXPERIMENTAL

GR1405 injection

Intervention Type: DRUG

Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks.

GR1405 injection 10 mg/kg

According to the patient's weight, the dose of this group is 10mg/kg.

Group Type: EXPERIMENTAL

GR1405 injection

Intervention Type: DRUG

Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks.

GR1405 injection 20 mg/kg

According to the patient's weight, the dose of this group is 20mg/kg.

Group Type: EXPERIMENTAL

GR1405 injection

Intervention Type: DRUG

Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks.

GR1405 injection 30 mg/kg

According to the patient's weight, the dose of this group is 30mg/kg.

Group Type: EXPERIMENTAL

GR1405 injection

Intervention Type: DRUG

Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks.

Interventions

GR1405 injection

Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks.

Intervention Type: DRUG

Other Intervention Names

PD-L1 monoclonal antibody

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Shi Yuankai

Vice-president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yuankai Shi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Locations

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

Beijing, , China

Countries

China

Central Contacts

yuankai Shi, M.D.

Role: CONTACT

syuankaipumc@126.com

86 010-87788293

References

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Other Identifiers

GR1405-002

Identifier Type: -

Identifier Source: org_study_id