Evidence map›Paper›PMID 36747118›Full record

Trial reportBMC cancer2023

Safety and efficacy of Pucotenlimab (HX008) - a humanized immunoglobulin G4 monoclonal antibody in patients with locally advanced or metastatic melanoma: a single-arm, multicenter, phase II study.

Chuanliang Cui, Yu Chen, Zhiguo Luo, Zhengyun Zou, Yu Jiang, Hongming Pan, Qingxia Fan, Jianfu Zhao, Qing Xu, Renbing Jiang and 10 more

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

Trial report in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04749485 (A Single-armed Open-labeled Phase II Study of HX008), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 8% 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.

NCT04749485 phase2unknown statusnot on this map

A Single-armed Open-labeled Phase II Study of HX008 (a Humanized Monoclonal Antibody Targeting PD-1) for the Treatment of Patients With Locally Advanced or Metastatic Melanoma Who Have Failed the Standard Treatments.

TypeinterventionalSponsorTaizhou Hanzhong biomedical co. LTDRan2018 to 2021Enrolled119ConditionsMelanomaArmsHX008
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Signal pathways of melanoma and targeted therapy.Signal transduction and targeted therapy · 2021
    Review
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 11 institutions in 2 countries.

Chuanliang Cui *Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital & Institute, Beijing, China.
Yu Chen *Fujian Cancer Hospital, Fuzhou, China.
Zhiguo LuoFudan University Shanghai Cancer Center, Shanghai, China.
Zhengyun ZouDrum Tower Hospital, Affiliated to Medical School of Nanjing University, Nanjing, China.
Yu JiangWest China Hospital, Sichuan University, Chengdu, China.
Hongming PanZhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, China.
Qingxia FanThe First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Jianfu ZhaoThe First Affiliated Hospital of Jinan University, Guangzhou, China.
Qing XuShanghai Tenth People's Hospital, Shanghai, China.
Renbing JiangThe Affiliated Cancer Hospital of Xinjiang Medical University, Ürümqi, China.
Xuan WangKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital & Institute, Beijing, China.
Taiyang MaTaizhou Hanzhong Biomedical Co., Ltd. (A Member of Lepu Biopharma Co., Ltd.), Taizhou, China.
Zhen GuoThe First Hospital of Jilin University, Changchun, China.
Lu SiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital & Institute, Beijing, China.
Zhihong ChiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital & Institute, Beijing, China.
Xinan ShengKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital & Institute, Beijing, China.
Yiwei DouTaizhou Hanzhong Biomedical Co., Ltd. (A Member of Lepu Biopharma Co., Ltd.), Taizhou, China.
Qian TanTaizhou Hanzhong Biomedical Co., Ltd. (A Member of Lepu Biopharma Co., Ltd.), Taizhou, China.
Di WuThe First Hospital of Jilin University, Changchun, China. wudi1971@jlu.edu.cn.ORCID http://orcid.org/0000-0003-1870-798X
Jun GuoKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital & Institute, Beijing, China. guoj307@126.com.ORCID http://orcid.org/0000-0003-1759-0986
Peking University · CNJilin University · CNFirst Affiliated Hospital of Jinan University · CNFirst Affiliated Hospital of Zhengzhou University · CNFudan University Shanghai Cancer Center · CNFujian Provincial Cancer Hospital · CNNanjing Drum Tower Hospital · CNShanghai Tenth People's Hospital · CNSichuan University · CNSir Run Run Shaw Hospital · CNXinjiang Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPucotenlimab is a novel recombinant humanized anti-PD-1 (Programmed death-1) monoclonal antibody, which belongs to the human IgG4/kappa subtype, and can selectively block the binding of PD-1 with its ligands PD-L1 and PD-L2.

methodsIn this phase 2 trial, patients with locally advanced or metastatic melanoma who had failed conventional treatment (chemotherapy, targeted therapy, interferon, IL-2, et al.) were recruited. The patients were administrated with Pucotenlimab of 3 mg/kg every 3 weeks until disease progression, intolerable toxicity, or treatment discontinuation for any other reasons. The primary endpoint was the overall response rate (ORR). The secondary endpoints were disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and toxicity.

resultsOne-hundred and nineteen patients were enrolled and followed up for 19.32 (ranging from 15.901 to 24.608) months by the cutoff date of July 30

conclusionsPucotenlimab as a ≥ 2

trial registrationClinicaltrials.gov Identifier: NCT04749485 (registered retrospectively on 11/02/2021).

Indexed as

Antibodies, Monoclonal, HumanizedMelanomaAntibodies, MonoclonalHumansImmune Checkpoint InhibitorsImmunoglobulin GRetrospective StudiesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedImmune Checkpoint InhibitorsImmunoglobulin GHX008MelanomaMonoclonal antibodyPD-1Pucotenlimab

Identifiers

PMID36747118
PMCPMC9901108
OpenAlexW4319298511

What OpenQuestion holds

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LicenceCC BY
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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.