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Case Report Open Access

Adverse events induced by the subcutaneous HER2-targeted antibody‑drug conjugate JSKN033 in a male patient with breast cancer: A case report

  • Authors:
    • Rui Yang
    • Jian Zhang
    • Yang Wang
  • View Affiliations / Copyright

    Affiliations: Department of Nursing, Fudan University Shanghai Cancer Center, Shanghai 200032, P.R. China, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, P.R. China, Department of Nursing, Fudan University Shanghai Cancer Center, Shanghai 200032, P.R. China
    Copyright: © Yang et al. This is an open access article distributed under the terms of Creative Commons Attribution License.
  • Article Number: 43
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    Published online on: November 24, 2025
       https://doi.org/10.3892/ol.2025.15396
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Abstract

JSKN033 is a fixed‑dose combination of JSKN003 [a biparatopic HER2‑directed antibody‑drug conjugate (ADC)] and envafolimab (a programmed death‑ligand 1 inhibitor). JSKN033 is formulated for subcutaneous administration and is currently in the investigational stage, with limited safety profile data. The present report highlights the case of a male patient with breast cancer with HER2 2+ expression who experienced disease progression after multiline therapy, including modified radical mastectomy, adjuvant chemotherapy, adjuvant radiotherapy and trastuzumab emtansine. Following enrollment in the JSKN033 clinical trial, the patient developed systemic and localized adverse reactions after treatment, including fatigue, diarrhea and injection‑site reactions, such as pruritus, pain, skin indentation and induration. The present case report discusses potential etiologies of these adverse events and issues to consider during subcutaneous administration of HER2‑directed ADCs, and provides supplementary clinical data to potentially advance the understanding of their adverse event profiles, mechanisms, prevention and management strategies.
View Figures

Figure 1

PET-CT scan (December 2023) revealing
metastatic recurrence. (A and B) Multiple pulmonary metastases in
both lungs. (C and D) Chest wall recurrence and axillary lymph node
metastases. In panels (A-D), the top-left image is a PET scan, the
top-right is a CT scan, the bottom-left is a fused PET-CT image and
the bottom-right is a whole-body PET scan. PET, positron emission
tomography; CT, computed tomography.

Figure 2

Timeline of treatment interventions
and AEs. Each administration required two separate subcutaneous
injections (2+1.1 ml), with injection sites within the same
anatomical region spaced ≥2.5 cm apart (administration nos. 3, 4,
7, 8, 9, 10 and 13). CTCAE, Common Terminology Criteria for Adverse
Events; AEs, adverse events; LVEF, left ventricular ejection
fraction; hs-TnT, high-sensitivity troponin T.

Figure 3

Erythema and hyperpigmentation
following left medial thigh injection (image captured in March
2025). Appearance at 1 week after the ninth injection in March
2025, showing an area measuring ~7×6 cm.

Figure 4

Subcutaneous indentation and
induration following abdominal injection (image captured in March
2025). (A and B) Appearance at 8 weeks after the second injection
in January 2025, showing an area measuring ~4×2 and 2.5×2.5 cm. (C
and D) Appearance at 9 weeks after the first injection in January
2025, showing areas measuring ~7×5 and 5×4 cm. All cutaneous
abnormalities presented occurred following single injections at
each site.
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Copy and paste a formatted citation
Spandidos Publications style
Yang R, Zhang J and Wang Y: Adverse events induced by the subcutaneous HER2-targeted antibody‑drug conjugate JSKN033 in a male patient with breast cancer: A case report. Oncol Lett 31: 43, 2026.
APA
Yang, R., Zhang, J., & Wang, Y. (2026). Adverse events induced by the subcutaneous HER2-targeted antibody‑drug conjugate JSKN033 in a male patient with breast cancer: A case report. Oncology Letters, 31, 43. https://doi.org/10.3892/ol.2025.15396
MLA
Yang, R., Zhang, J., Wang, Y."Adverse events induced by the subcutaneous HER2-targeted antibody‑drug conjugate JSKN033 in a male patient with breast cancer: A case report". Oncology Letters 31.1 (2026): 43.
Chicago
Yang, R., Zhang, J., Wang, Y."Adverse events induced by the subcutaneous HER2-targeted antibody‑drug conjugate JSKN033 in a male patient with breast cancer: A case report". Oncology Letters 31, no. 1 (2026): 43. https://doi.org/10.3892/ol.2025.15396
Copy and paste a formatted citation
x
Spandidos Publications style
Yang R, Zhang J and Wang Y: Adverse events induced by the subcutaneous HER2-targeted antibody‑drug conjugate JSKN033 in a male patient with breast cancer: A case report. Oncol Lett 31: 43, 2026.
APA
Yang, R., Zhang, J., & Wang, Y. (2026). Adverse events induced by the subcutaneous HER2-targeted antibody‑drug conjugate JSKN033 in a male patient with breast cancer: A case report. Oncology Letters, 31, 43. https://doi.org/10.3892/ol.2025.15396
MLA
Yang, R., Zhang, J., Wang, Y."Adverse events induced by the subcutaneous HER2-targeted antibody‑drug conjugate JSKN033 in a male patient with breast cancer: A case report". Oncology Letters 31.1 (2026): 43.
Chicago
Yang, R., Zhang, J., Wang, Y."Adverse events induced by the subcutaneous HER2-targeted antibody‑drug conjugate JSKN033 in a male patient with breast cancer: A case report". Oncology Letters 31, no. 1 (2026): 43. https://doi.org/10.3892/ol.2025.15396
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