Evidence map›Paper›PMID 39216478›Full record

ArticleCell reports. Medicine2024

Phase 1a study of ESG401, a Trop2 antibody-drug conjugate, in patients with locally advanced/metastatic solid tumors.

Jiani Wang, Zhongsheng Tong, Yinuo Tan, Yehui Shi, Yun Wu, Qing Zhou, Xiaoyan Xing, Xiaomei Chen, Fuming Qiu, Fei Ma

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Cell reports. Medicine, 2024. 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 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

  1. Review
  2. Review
  3. Progress of Trop-2-targeted antibody-drug conjugates in HER-2-negative breast cancer: a mini-review.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026
    Review
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Current landscape of sequencing ADCs in metastatic breast cancer.Therapeutic advances in medical oncology · 2025
    Review
  11. Recent advances in systematic therapy of breast cancer: Chinese contribution for international progress.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2024
    Article
  12. 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

10 authors.

Jiani 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.
Zhongsheng TongDepartment of Breast Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.
Yinuo TanDepartment of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China; Cancer Institute, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Yehui ShiDepartment of Breast Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.
Yun 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.
Qing ZhouShanghai Escugen Biotechnology Co., Ltd., Shanghai, China.
Xiaoyan XingShanghai Escugen Biotechnology Co., Ltd., Shanghai, China.
Xiaomei ChenShanghai Escugen Biotechnology Co., Ltd., Shanghai, China.
Fuming QiuDepartment of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China; Cancer Institute, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China; Key Laboratory of Tumor Microenvironment and Immune Therapy of Zhejiang Province, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. Electronic address: qiufuming@zju.edu.cn.
Fei 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

This phase 1a study assesses ESG401 in patients with heavily pretreated locally advanced or metastatic solid tumors, focusing on metastatic breast cancer. Forty patients are enrolled: three experience dose-limiting toxicities, establishing the maximum tolerated dose at 16 mg/kg on days 1, 8, and 15 of a 28-day cycle. The most common grade ≥3 treatment-related adverse events are neutropenia and leukopenia. Among 38 efficacy-evaluable patients, the objective response rate (ORR) is 34.2%, the disease control rate (DCR) is 65.8%, and the clinical benefit rate (CBR) is 50.0% (including stable disease for at least 6 months). The median progression-free survival is 5.1 months, and the median duration of response is 6.3 months. In patients receiving therapeutically relevant doses, the ORR, DCR, and CBR are 40.6%, 75.0%, and 56.3%, respectively. ESG401 demonstrates a favorable safety profile and promising antitumor activity in this heavily treated population. The trial is registered at ClinicalTrials.gov (NCT04892342).

Indexed as

Antigens, NeoplasmImmunoconjugatesNeoplasm MetastasisAdultAgedCell Adhesion MoleculesFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasmsProgression-Free SurvivalAntigens, NeoplasmCell Adhesion MoleculesImmunoconjugatesTACSTD2 protein, humanADCantibody drug conjugatemetastatic breast cancerSN-38solid tumorsTROP2trophoblast cell-surface antigen 2

Identifiers

PMID39216478
PMCPMC11524954

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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.