Evidence map›Paper›PMID 40359710›Full record

ArticleESMO open2025

Novel TROP2 antibody-drug conjugates for treatment of HER2-negative metastatic breast cancer patients with brain metastases: a promising option

J Wang, Y Zhang, R Bai, Y Wu, Z Tong, A Liu, Y Zhang, H Wang, X Wu, Y Cheng and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04892342 (An Open-Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I/II Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of ESG401 in Subjects With Locally Advanced/Metastatic Solid Tumors), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

NCT04892342 phase1 / phase2completednot on this map

An Open-Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I/II Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of ESG401 in Subjects With Locally Advanced/Metastatic Solid Tumors

TypeinterventionalSponsorShanghai Escugen Biotechnology Co., LtdRan2021 to 2025Enrolled156ConditionsNeoplasms, Breast, Neoplasms, Lung, Neoplasms,Colorectal, Neoplasms, BladderArmsESG401
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Article
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

16 authors.

J WangDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Y ZhangDepartment of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
R BaiDepartment of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Y WuDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Z TongDepartment of Breast Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.
A LiuDepartment of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
Y ZhangDepartment of Oncology, Beijing Hospital, Beijing, China.
H WangDepartment of Oncology, Nanchang People's Hospital Affiliated of Nanchang Medical College, Nanchang, China.
X WuDepartment of Oncology, Hubei Cancer Hospital, Hubei, China.
Y ChengDepartment of Oncology, Jilin Cancer Hospital, Changchun, China.
H YangDepartment of Oncology, Affiliated Hospital of Hebei University, Baoding, China.
Q ZhouShanghai Escugen Biotechnology Co., Ltd, Shanghai, China.
X XingShanghai Escugen Biotechnology Co., Ltd, Shanghai, China.
X ChenShanghai Escugen Biotechnology Co., Ltd, Shanghai, China.
F QiuDepartment of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; Cancer Institute, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; Key Laboratory of Tumor Microenvironment and Immune Therapy of Zhejiang Province, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. Electronic address: qiufuming@zju.edu.cn.
F MaDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: drmafei@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundESG401 is a further optimized antibody-drug conjugate comprising a humanized anti-trophoblast cell-surface antigen 2 immunoglobulin G1 monoclonal antibody conjugated to SN-38, a topoisomerase I inhibitor, via a proprietary novel stable linker. The analysis aimed to explore the efficacy of ESG401 in human epidermal growth factor receptor 2 (HER2)-negative breast cancer (BC) patients with brain metastases (BMs), a population urging significant clinical need with limited systematic treatment options. PATIENTS AND

methodsThis subgroup analysis was conducted as part of an open-label, multi-dose, dose-escalation, and cohort-expansion multicenter phase I trial. Eligible participants were aged 18-75 years and had locally advanced or metastatic solid tumors. For this subgroup analysis, patients with histologically confirmed HER2-negative BC and BMs were enrolled. Efficacy endpoints included overall objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS). Intracranial-specific endpoints included intracranial ORR (iORR), intracranial DCR (iDCR), and intracranial PFS. This trial is registered at ClinicalTrials.gov, NCT04892342.

resultsAmong 17 patients with efficacy-evaluable BMs, the iORR was 41% (7/17) [95% confidence interval (CI) 18.4% to 67.1%] including 3 patients achieving an intracranial complete response. The iDCR was 76% (13/17) (95% CI 50.1% to 93.2%). The overall ORR was 53% (9/17) (95% CI 27.8% to 77.0%), the overall DCR was 71% (12/17) (95% CI 44.0% to 89.7%), and the medium PFS was 5.7 months. The safety profile was consistent with previous reports.

conclusionsThese findings suggest that ESG401 is a promising and well-tolerated treatment option for BMs.

Indexed as

Antigens, NeoplasmBrain NeoplasmsBreast NeoplasmsCamptothecinCell Adhesion MoleculesImmunoconjugatesAdolescentAdultAgedErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedYoung AdultAntigens, NeoplasmCamptothecinCell Adhesion MoleculesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesTACSTD2 protein, humanADCbrain metastasesbreast cancerTROP2

Identifiers

PMID40359710
PMCPMC12141909

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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.