Evidence map›Paper›PMID 32256049›Full record

ArticleDrug design, development and therapy2020

A First-in-Human Dose Finding Study of Camrelizumab in Patients with Advanced or Metastatic Cancer in Australia.

Jason D Lickliter, Hui K Gan, Mark Voskoboynik, Surein Arulananda, Bo Gao, Adnan Nagrial, Peter Grimison, Michelle Harrison, Jianjun Zou, Lianshan Zhang and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Drug design, development and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02492789 (An Open-Label, Multicenter, Nonrandomized, Dose-Escalation and Tumor-Expansion Phase 1 Study to Evaluate the Safety and Tolerability of INCSHR01210), which is not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02492789 phase1completednot on this map

An Open-Label, Multicenter, Nonrandomized, Dose-Escalation and Tumor-Expansion Phase 1 Study to Evaluate the Safety and Tolerability of INCSHR01210 (Formerly SHR-1210) in Subjects With Advanced Solid Tumors

TypeinterventionalSponsorAtridia Pty Ltd.Ran2015 to 2019Enrolled49ConditionsSolid Tumors and Hematologic MalignancyArmsINCSHR01210 injection
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

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  11. Phase I study of camrelizumab in patients with advanced solid tumors.Signal transduction and targeted therapy · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 9 institutions in 3 countries.

Jason D LickliterNucleus Network, Melbourne, Victoria, Australia.
Hui K GanDepartment of Medicine, University of Melbourne, Heidelberg, Victoria, Australia.
Mark VoskoboynikNucleus Network, Melbourne, Victoria, Australia.ORCID 0000-0002-4242-1300
Surein ArulanandaDepartment of Medicine, University of Melbourne, Heidelberg, Victoria, Australia.
Bo GaoBlacktown Cancer and Haematology Centre, Blacktown Hospital, University of Sydney, Sydney, New South Wales, Australia.
Adnan NagrialBlacktown Cancer and Haematology Centre, Blacktown Hospital, University of Sydney, Sydney, New South Wales, Australia.
Peter GrimisonDepartment of Medical Oncology, Chris O'Brien Life House, Camperdown, New South Wales, Australia.
Michelle HarrisonDepartment of Medical Oncology, Chris O'Brien Life House, Camperdown, New South Wales, Australia.
Jianjun ZouJiangsu Hengrui Medicine Co. Ltd, Shanghai, People's Republic of China.
Lianshan ZhangJiangsu Hengrui Medicine Co. Ltd, Shanghai, People's Republic of China.
Stacey LuoJiangsu Hengrui Medicine Co. Ltd, Shanghai, People's Republic of China.
Michael LahnIncyte Biosciences International Sarl, Geneva, Switzerland.ORCID 0000-0002-1377-7308
Howard KallenderIncyte Corporation, Wilmington, Delaware, USA.ORCID 0000-0001-5634-883X
Andrea MannucciIncyte Biosciences International Sarl, Geneva, Switzerland.
Catello SommaIncyte Biosciences International Sarl, Geneva, Switzerland.ORCID 0000-0002-9752-4200
Katherine WoodsOlivia Newton-John Cancer Wellness and Research Centre, Austin Hospital, Melbourne, Victoria, Australia.ORCID 0000-0003-3474-3104
Andreas BehrenOlivia Newton-John Cancer Wellness and Research Centre, Austin Hospital, Melbourne, Victoria, Australia.ORCID 0000-0001-5329-280X
Pablo Fernandez-PenasDepartment of Dermatology, The University of Sydney, Westmead Hospital, Westmead, New South Wales, Australia.ORCID 0000-0003-4882-1564
Michael MillwardLinear Clinical Research, Nedlands, Western Australia, Australia.ORCID 0000-0002-1744-1617
Tarek MeniawyLinear Clinical Research, Nedlands, Western Australia, Australia.
Jiangsu Hengrui Medicine (China) · CNThe University of Sydney · AUChris O’Brien Lifehouse · AULinear Clinical Research · AUThe University of Melbourne · AUAustin Hospital · AUIncyte (United States) · USLa Trobe University · AUThe Alfred Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCamrelizumab inhibits PD-1 in non-clinical models and showed typical non-clinical pharmacokinetic (PK) and safety profiles for an IgG4 monoclonal antibody. We report results from the First-in-Human Phase 1 trial of camrelizumab in Australian population.

methodsCamrelizumab was administered to patients with advanced solid tumors who had failed standard therapies. In the dose-escalation phase (n=23), camrelizumab was administered intravenously at 1 mg/kg, 3 mg/kg, 6 mg/kg, and 10 mg/kg every 2 weeks. In dose expansion (n=26), camrelizumab was given at 200 mg or 600 mg every 4 weeks.

resultsTwo dose-limiting toxicities were observed during dose escalation: transaminase elevation and diarrhea (both grade 3). Overall, treatment-related adverse events were consistent with the expected toxicity profile of immune checkpoint inhibition, with the striking exception of the dose-related development of angiomatous skin lesions characterized as reactive cutaneous capillary endothelial proliferation. The PK profile showed a dose-progressive increase in half-life from 3 days at 1 mg/kg to 7 days at 10 mg/kg. Moreover, receptor occupancy assays showed a PD-1 occupancy of >50% in most patients out to 28 days post-dose. The objective response rate was 15.2% (95% CI 6.3-28.9).

conclusionCamrelizumab has manageable toxicity and encouraging preliminary antitumor activity in advanced solid tumors in Australia. CLINICAL

trial registrationClinicalTrials.gov Identifier: NCT02492789.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAustraliaBiliary Tract NeoplasmsDose-Response Relationship, DrugEndometrial NeoplasmsFemaleHumansInjections, IntravenousMaleMaximum Tolerated DoseMiddle AgedThymus NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Agentscamrelizumabcancerfirst-in-human dose studymonoclonal antibodyPD-1reactive cutaneous capillary endothelial proliferation

Identifiers

PMID32256049
PMCPMC7090185
OpenAlexW3011848654

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.