Status unknownNCT03731390Updated Nov 6, 2018

GR1405 Injection in Patients With Advanced Solid Tumor or Lymphoma

A Phase 1 interventional study of GR1405 injection in Tumor, Solid and Lymphoma, sponsored by Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-11-06.

Sponsored by Chinese Academy of Medical Sciences · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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

Read the 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 studied

Tumor, Solid
Lymphoma

Browse trials for

Lymphoma 5,578

Keywords

programmed death ligand-1 (PD-L1)

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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;
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;
Receive a live attenuated vaccine within 4 weeks prior to the first dose of study treatment or during the study period;
Other subjects judged by the investigator to be ineligible for enrollment in the study.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 30 participants (estimated)

Study arms

Experimental
GR1405 injection 3 mg/kg
According to the patient's weight, the dose of this group is 3mg/kg.
Drug: GR1405 injection
Experimental
GR1405 injection 10 mg/kg
According to the patient's weight, the dose of this group is 10mg/kg.
Drug: GR1405 injection
Experimental
GR1405 injection 20 mg/kg
According to the patient's weight, the dose of this group is 20mg/kg.
Drug: GR1405 injection
Experimental
GR1405 injection 30 mg/kg
According to the patient's weight, the dose of this group is 30mg/kg.
Drug: GR1405 injection

Interventions

DrugGR1405 injection
Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks.
Also known as: PD-L1 monoclonal antibody

What researchers measure

Primary outcomes

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

Secondary outcomes

maximum concentration (Cmax)
the maximum exposure to a biologically active physica
Time frame: Approximately 2 years
Duration of response (DOR)
DOR by RECIST v. 1.1 or Lugano 2014, the time between the initial response to therapy and subsequent disease progression or relapse
Time frame: Approximately 3 years
Objective Response Rate(ORR)
Objective Response Rate(ORR) by RECIST v. 1.1 or Lugano 2014, ORR=complete response(CR) + partial response(PR)
Time frame: Approximately 3 years
Progression free survival(PFS)
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
Time frame: Approximately 3 years
Immunogenicity
the ability to elicit an immune response of GR1405 injection,
Time frame: Approximately 3 years
Recommended dose for Phase II trial(RP2D)
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
Time frame: Approximately 3 years
AUC0-t
Area under the curve in the period from 0 to t
Time frame: Approximately 2 years
AUC0-∞
Area under the curve in the period from 0 to ∞
Time frame: Approximately 2 years
AUCss
Area under the curve of Steady-State Plasma Concentrations
Time frame: Approximately 2 years
T max
the time of occurrence of peak drug concentration
Time frame: Approximately 2 years
t 1/2
the time of half-life of the drug
Time frame: Approximately 2 years
apparent volume of distribution (Vz)
the volume of fluid that would be required to contain the amount of drug in the body
Time frame: Approximately 2 years
clearance(CL)
the rate of elimination of the drug in vivo
Time frame: Approximately 2 years

Study locations

1 site

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

References and documents

Publications

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. PubMed 28434648 ↗
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. Erratum In: Lancet. 2017 Aug 26;390(10097):848. doi: 10.1016/S0140-6736(17)32213-4. PubMed 27939400 ↗
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. PubMed 28822576 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03731390
Lead sponsor: Chinese Academy of Medical Sciences
Responsible party: Shi Yuankai (Vice-president, Chinese Academy of Medical Sciences) — Principal investigator
First posted: Nov 6, 2018
Start date: Nov 2018 (estimated)
Primary completion: Oct 2019 (estimated)
Completion: Oct 2021 (estimated)
Last update: Nov 6, 2018

Study contacts

yuankai Shi, M.D.

Contact

syuankaipumc@126.com

86 010-87788293

yuankai Shi, M.D.

principal investigator · Chinese Academy of Medical Sciences

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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