GR1405 Injection in Patients With Advanced Solid Tumor or Lymphoma

NCT03731390 | Unknown Phase 1

• 1 other identifier: GR1405-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Tumor, Solid; Lymphoma

Keywords

programmed death ligand-1 (PD-L1)

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD)

  Maximum tolerated dose of GR1405 injection

  2 weeks

• Adverse Events

  Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v4.03

  Approximately 3 years

Secondary Outcomes (13)

• maximum concentration (Cmax)

  Approximately 2 years

• Duration of response (DOR)

  Approximately 3 years

• Objective Response Rate(ORR)

  Approximately 3 years

• Progression free survival(PFS)

  Approximately 3 years

• Immunogenicity

  Approximately 3 years

Study Arms (4)

GR1405 injection 3 mg/kg

EXPERIMENTAL

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

Drug: GR1405 injection

GR1405 injection 10 mg/kg

EXPERIMENTAL

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

Drug: GR1405 injection

GR1405 injection 20 mg/kg

EXPERIMENTAL

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

Drug: GR1405 injection

GR1405 injection 30 mg/kg

EXPERIMENTAL

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

Drug: GR1405 injection

Interventions

GR1405 injection DRUG

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

Also known as: PD-L1 monoclonal antibody

GR1405 injection 10 mg/kg; GR1405 injection 20 mg/kg; GR1405 injection 3 mg/kg; GR1405 injection 30 mg/kg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• Subjects who have alcohol addiction and/or drug abuse;
• 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);
• Subjects with allergic constitution or allergic to known components of the drug;
• Those who received other clinical trial drug therapy within 1 month before the first administration;

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

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

Beijing, China

Location

Related Publications (3)

• El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, Kim TY, Choo SP, Trojan J, Welling TH Rd, Meyer T, Kang YK, Yeo W, Chopra A, Anderson J, Dela Cruz C, Lang L, Neely J, Tang H, Dastani HB, Melero I. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017 Jun 24;389(10088):2492-2502. doi: 10.1016/S0140-6736(17)31046-2. Epub 2017 Apr 20.

  PMID: 28434648 BACKGROUND

• Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Duran I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE 3rd, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thastrom A, Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76. doi: 10.1016/S0140-6736(16)32455-2. Epub 2016 Dec 8.

  PMID: 27939400 BACKGROUND

• Schachter J, Ribas A, Long GV, Arance A, Grob JJ, Mortier L, Daud A, Carlino MS, McNeil C, Lotem M, Larkin J, Lorigan P, Neyns B, Blank C, Petrella TM, Hamid O, Zhou H, Ebbinghaus S, Ibrahim N, Robert C. Pembrolizumab versus ipilimumab for advanced melanoma: final overall survival results of a multicentre, randomised, open-label phase 3 study (KEYNOTE-006). Lancet. 2017 Oct 21;390(10105):1853-1862. doi: 10.1016/S0140-6736(17)31601-X. Epub 2017 Aug 16.

  PMID: 28822576 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• yuankai Shi, M.D.

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yuankai Shi, M.D.

CONTACT

86 010-87788293; syuankaipumc@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-president

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 6, 2018
• Study Start: November 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2021
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)