Evidence map›Paper›PMID 38886347›Full record

ArticleNature communications2024

HER2-targeting antibody drug conjugate FS-1502 in HER2-expressing metastatic breast cancer: a phase 1a/1b trial.

Qiao Li, Ying Cheng, Zhongsheng Tong, Yunjiang Liu, Xian Wang, Min Yan, Jianhua Chang, Shusen Wang, Caiwen Du, Liang Li and 11 more

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

Article in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03944499 (A Phase I,Multicenter,Open-label,Single-arm Study), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

NCT03944499 phase1completednot on this map

A Phase I,Multicenter,Open-label,Single-arm Study:A Dose-escalation Phase Evaluating FS1502 in Patients With HER2 Expressed Advanced Solid Tumors,and a Dose-expanded Phase in Patients With Local Advanced or Metastatic,HER2+ Breast Cancer

TypeinterventionalSponsorShanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Ran2019 to 2024Enrolled161ConditionsSolid Tumor, Breast CancerArmsFS-1502
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Review
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  8. Review
  9. Article
  10. Review
  11. Review
  12. Current landscape of sequencing ADCs in metastatic breast cancer.Therapeutic advances in medical oncology · 2025
    Review
  13. 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
  14. 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

21 authors.

Qiao LiDepartment of Medical Oncology, State Key Laboratory, National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Ying ChengDepartment of Oncology, Jilin Cancer Hospital, Changchun, China.ORCID http://orcid.org/0000-0001-9908-597X
Zhongsheng TongDepartment of Breast Medical Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Yunjiang LiuDepartment of Breast Center, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Xian WangDepartment of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Min YanDepartment of Breast Medicine, Henan Cancer Hospital, Zhengzhou, Henan, China.ORCID http://orcid.org/0000-0002-3911-748X
Jianhua ChangDepartment of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, China.
Shusen WangSun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.ORCID http://orcid.org/0000-0003-0139-5780
Caiwen DuDepartment of Medical Oncology, Meizhou People's Hospital, Meizhou, Guangdong, China.
Liang LiDepartment of Medical Oncology, Meizhou People's Hospital, Meizhou, Guangdong, China.
Chunjiao WuDepartment of Oncology, Jilin Cancer Hospital, Changchun, China.
Mingxia WangDepartment of Clinical Pharmacology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Zhuo WangDepartment of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Zhuli WuShanghai Fosun Pharmaceutical Industrial Development Co., Ltd., Shanghai, China.
Xingli WangShanghai Fosun Pharmaceutical Industrial Development Co., Ltd., Shanghai, China.
Yongli JinShanghai Fosun Pharmaceutical Development Co., Ltd., Shanghai, China.
Lei DiaoShanghai Fosun Pharmaceutical Development Co., Ltd., Shanghai, China.
Yi SunShanghai Fosun Pharmaceutical Development Co., Ltd., Shanghai, China.
Yongjiao ZhangShanghai Fosun Pharmaceutical Development Co., Ltd., Shanghai, China.
Ai-Min HuiEnCureGen Pharma, Guangzhou, China.
Binghe XuDepartment of Medical Oncology, State Key Laboratory, National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. xubinghe@medmail.com.cn.ORCID http://orcid.org/0000-0003-4195-337X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Currently approved HER2-targeting antibody-drug conjugates (ADCs) for HER2-positive breast cancer (BC) are associated with safety concerns. In this multicenter, single-arm, dose-escalation (phase 1a) and dose-expansion (phase 1b) phase 1 trial (NCT03944499), patients with HER2-expressing advanced solid tumors received FS-1502 (an anti-HER2 ADC) with a 3 + 3 design in phase 1a; patients with metastatic HER2-positive BC received FS-1502 at the recommended phase 2 dose (RP2D) in phase 1b. The primary end points were dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and RP2D for phase 1a and objective response rate (ORR) for phase 1b. A total of 150 patients with HER2-expressing solid tumors (n = 5) and BC (n = 145) were enrolled (female, n = 146, 97.3%). One DLT each was reported at 3.0 and 3.5 mg/kg; the MTD was not reached. The RP2D was 2.3 mg/kg once every 3 weeks. Five (3.3%) patients experienced pneumonitis; four (2.7%) had grade 3 reversible ocular events. Of 67 HER2-positive BC patients receiving the RP2D, the best ORR was 53.7% (95% CI, 41.1-66.0%), including PRs confirmed (confirmed ORR, 37.5%) and pending for confirmation. FS-1502 was well tolerated with limited ocular and pulmonary findings and demonstrated promising antitumor activity in HER2-positive BC patients.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesImmunoconjugatesMaximum Tolerated DoseAdultAgedAged, 80 and overFemaleHumansMiddle AgedNeoplasm MetastasisERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugates

Identifiers

PMID38886347
PMCPMC11183070

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Registered trials

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