Evidence map›Paper›PMID 41321671›Full record

ArticleDrug design, development and therapy2025

Phase 1b Multicenter Study of SG001, a Humanized Anti-PD-1 Antibody, in Patients with Advanced Solid Tumors.

Jian Fang, Ou Jiang, Wei Li, Jie Lin, Meiyu Fang, Qun Li, Weihong Zhao, Ke Wang, Huaqiu Shi, Zhendong Chen and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Drug design, development and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03852823 (An Open, Multi-dose, Dose Escalation and Cohort Expansion, Phase Ⅰ Study of the Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours.), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

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

NCT03852823 phase1unknown statusnot on this map

An Open, Multi-dose, Dose Escalation and Cohort Expansion, Phase Ⅰ Study of the Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours.

TypeinterventionalSponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.Ran2019 to 2023Enrolled192ConditionsAdvanced Solid Tumours, Cervical Cancer, Malignant Mesothelioma, LymphomaArmsSG001
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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.

Jian FangDepartment of Thoracic Oncology, Peking University Cancer Hospital, Beijing, People's Republic of China.ORCID 0000-0003-3697-4563
Ou JiangDepartment of Cancer Center, Second People's Hospital of Neijiang, Neijiang, People's Republic of China.ORCID 0000-0002-1971-0534
Wei LiDepartment of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University Medical School Cancer Institute, Tongji University School of Medicine, Shanghai, People's Republic of China.
Jie LinDepartment of Medical Oncology, The Second Affiliated Hospital of Kunming Medical University, Kunming, People's Republic of China.
Meiyu FangDepartment of Chemotherapy, Chinese Academy of Sciences University Cancer Hospital (Zhejiang Cancer Hospital), Hangzhou, People's Republic of China.
Qun LiDepartment of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, People's Republic of China.
Weihong ZhaoDepartment of Medical Oncology, Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.
Ke WangDepartment of Gynaecological Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center of Cancer, Tianjin, People's Republic of China.
Huaqiu ShiDepartment of Oncology, The First Affiliated Hospital of Gannan Medical University, Ganzhou, People's Republic of China.
Zhendong ChenDepartment of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, People's Republic of China.
Junyan YuDepartment of Oncology, Heping Hospital of Changzhi Medical College, Changzhi, People's Republic of China.
Xiaojing XingDepartment of Medical Oncology, Liaoning Cancer Hospital and Institute, Shenyang, People's Republic of China.
Mingxuan ZhaoResearch center for early clinical trials of Drugs (Vaccines), Anning First People's Hospital Affiliated to Kunming University of Science and Technology, Anning, People's Republic of China.
Anwen LiuDepartment of Oncology, Second Affiliated Hospital of Nanchang University, Nanchang, People's Republic of China.
Wei WangDepartment of Medical Oncology, Hunan Cancer Hospital, Changsha, People's Republic of China.ORCID 0000-0001-8685-811X
Zhengquan HanDepartment of Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, People's Republic of China.
Silong XiangCSPC Zhongqi Pharmaceutical Technology Co., Ltd, Shijiazhuang, People's Republic of China.
Xiao ZhangCSPC Zhongqi Pharmaceutical Technology Co., Ltd, Shijiazhuang, People's Republic of China.
Jin Li *Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, People's Republic of China.ORCID 0000-0003-0099-874X
Caicun Zhou *Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University Medical School Cancer Institute, Tongji University School of Medicine, Shanghai, People's Republic of China.ORCID 0000-0002-6958-0766

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: SG001 is a humanized, IgG4 monoclonal antibody against human PD-1. This phase 1b study aimed to evaluate efficacy and safety of SG001 in advanced solid tumors. Methods: Patients with previously treated solid tumors that are PD-L1-positive, and/or dMMR/MSI-H, and/or Epstein-Barr virus positive were enrolled in Cohort A, while patients with PD-L1-unselected malignant mesothelioma and PD-L1-unselected non-small cell lung cancer (NSCLC) were enrolled in Cohorts C and E, respectively. All patients in Cohorts A, C, and E received SG001 at a dose of 240mg every two weeks for 2 years or until disease progression, intolerable toxicities, or withdrawal of consent. The primary endpoint was the investigator-assessed overall response rate (ORR). Results: A total of 87 patients were enrolled: 33 in Cohort A, 24 in Cohort C, and 30 in Cohort E. Investigator-assessed ORR was 39.4% in Cohort A, 12.5% in Cohort C, and 16.7% in Cohort E; corresponding median PFS values were 9.6, 4.1, and 4.0 months. The most common treatment-related adverse events (TRAEs) were increased alanine aminotransferase (13.8%), proteinuria (12.6%), rash (12.6%), and increased aspartate aminotransferase (10.3%). No TRAEs leading to death were reported. Conclusion: SG001 demonstrated promising activity in patients with pretreated advanced solid tumors, especially those with PD-L1-positive NSCLC. The safety profile was well tolerated. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03852823.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, Non-Small-Cell LungNeoplasmsProgrammed Cell Death 1 ReceptorAdultAgedAged, 80 and overDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalPDCD1 protein, humanProgrammed Cell Death 1 Receptorcheckpoint inhibitormesotheliomanon-small cell lung cancerprogrammed death-1 inhibitorsolid tumors

Identifiers

PMID41321671
PMCPMC12661951

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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.