Evidence map›Paper›PMID 33169186›Full record

Trial reportCancer chemotherapy and pharmacology2021

A Phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX02 to reference CN- and EU-sourced trastuzumab in healthy subjects.

X Zhu, Y Ding, Y Yu, M Wang, W Zhou, J Wang, X Zhu, H Zhang, M Wang, K Chai and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02581748 (A Phase I Study to Evaluate the Safety and Tolerability of Different Dosages of HLX02), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.1field-weighted citation impact, top 20% 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.

NCT02581748 phase1completednot on this map

A Phase I Study to Evaluate the Safety and Tolerability of Different Dosages of HLX02 (Open-label Part) and to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin® (US and Germany Sourced; Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects

TypeinterventionalSponsorShanghai Henlius BiotechRan2015 to 2017Enrolled123ConditionsHealthyArmsHLX02, Herceptin
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 20 citations in OpenAlex.

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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

15 authors at 2 institutions in 1 country.

X ZhuPhase 1 Clinical Trial Laboratory, The First Hospital of Jilin University, Changchun, China.
Y DingPhase 1 Clinical Trial Laboratory, The First Hospital of Jilin University, Changchun, China.
Y YuPhase 1 Clinical Trial Laboratory, The Second Affiliated Hospital of Soochow University, No. 1055 Sanxiang Road, Gusu District, Suzhou, 215004, China.
M WangPhase 1 Clinical Trial Laboratory, The Second Affiliated Hospital of Soochow University, No. 1055 Sanxiang Road, Gusu District, Suzhou, 215004, China.
W ZhouPhase 1 Clinical Trial Laboratory, The Second Affiliated Hospital of Soochow University, No. 1055 Sanxiang Road, Gusu District, Suzhou, 215004, China.
J WangInternal Medicine Oncology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
X ZhuDepartment of Cardiology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
H ZhangPhase 1 Clinical Trial Laboratory, The First Hospital of Jilin University, Changchun, China.
M WangPhase 1 Clinical Trial Laboratory, The First Hospital of Jilin University, Changchun, China.
K ChaiShanghai Henlius Biotech, Inc., Shanghai, China.
X ZhangShanghai Henlius Biotech, Inc., Shanghai, China.
A LukShanghai Henlius Biotech, Inc., Shanghai, China.
W JiangShanghai Henlius Biotech, Inc., Shanghai, China.
S LiuShanghai Henlius Biotech, Inc., Shanghai, China.
Q ZhangPhase 1 Clinical Trial Laboratory, The Second Affiliated Hospital of Soochow University, No. 1055 Sanxiang Road, Gusu District, Suzhou, 215004, China. sdfeyyq_zqy@163.com.ORCID 0000-0001-9870-2972
Jilin University · CNSoochow University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study evaluated the bioequivalence of China-manufactured biosimilar, HLX02, to reference China (CN)- and European Union (EU)-sourced trastuzumab.

methodsThis was a two-part Phase 1 study conducted in healthy Chinese males. Part 1 evaluated the safety of different doses of HLX02 (2, 4, 6 or 8 mg/kg; intravenous infusion over 90 min, n = 3 per group). Part 2, a randomized, double-blind study, investigated the pharmacokinetics (PK), safety and immunogenicity of study drugs (HLX02 [n = 37], CN-trastuzumab [n = 35] or EU-trastuzumab [n = 37] at the dose suggested by Part 1 results). The primary PK endpoint was the area under the serum concentration-time curve from time 0 to infinity (AUC

resultsIn Part 1, all doses of HLX02 were well tolerated and 6 mg/kg was suggested for Part 2. The GLSMRs and 90% CIs for AUC

conclusionThis study demonstrated comparable safety profiles and PK bioequivalence among HLX02, CN-trastuzumab and EU-trastuzumab in healthy Chinese male subjects. CLINICAL

trial registrationClinicalTrials.gov, NCT02581748, registered at October 19, 2015.

Indexed as

AdultAntineoplastic Agents, ImmunologicalArea Under CurveBiosimilar PharmaceuticalsChinaDose-Response Relationship, DrugDouble-Blind MethodHumansInfusions, IntravenousMaleTherapeutic EquivalencyTrastuzumabYoung AdultAntineoplastic Agents, ImmunologicalBiosimilar PharmaceuticalsTrastuzumabBioequivalenceBiosimilarBreast cancerPharmacokineticsTastuzumab

Identifiers

PMID33169186
OpenAlexW3099557102

What OpenQuestion holds

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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.