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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GR1405 injection 3 mg/kg | Experimental | According to the patient's weight, the dose of this group is 3mg/kg. |
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| GR1405 injection 10 mg/kg | Experimental | According to the patient's weight, the dose of this group is 10mg/kg. |
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| GR1405 injection 20 mg/kg | Experimental | According to the patient's weight, the dose of this group is 20mg/kg. |
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| GR1405 injection 30 mg/kg | Experimental | According to the patient's weight, the dose of this group is 30mg/kg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR1405 injection | Drug | Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| maximum concentration (Cmax) | the maximum exposure to a biologically active physica | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yuankai Shi, M.D. | Contact | 86 010-87788293 | syuankaipumc@126.com |
| Name | Affiliation | Role |
|---|---|---|
| yuankai Shi, M.D. | Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28434648 | Background | 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. | |
| 27939400 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| 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) | 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 | Approximately 3 years |
| Immunogenicity | the ability to elicit an immune response of GR1405 injection, | 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 | Approximately 3 years |
| AUC0-t | Area under the curve in the period from 0 to t | Approximately 2 years |
| AUC0-∞ | Area under the curve in the period from 0 to ∞ | Approximately 2 years |
| AUCss | Area under the curve of Steady-State Plasma Concentrations | Approximately 2 years |
| T max | the time of occurrence of peak drug concentration | Approximately 2 years |
| t 1/2 | the time of half-life of the drug | 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 | Approximately 2 years |
| clearance(CL) | the rate of elimination of the drug in vivo | Approximately 2 years |
| 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. |
| 28822576 | 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. |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |