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Poster session 01

649P - Phase I study of SHR-A2102, a nectin-4 targeted ADC, in patients with advanced solid tumors

Date

14 Sep 2024

Session

Poster session 01

Topics

Clinical Research

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Hua Zhong

Citation

Annals of Oncology (2024) 35 (suppl_2): S482-S535. 10.1016/annonc/annonc1589

Authors

H. Zhong1, R. Zhong1, R. Qiao2, Q. Lan3, M. Yan4, T. Zhang5, K. Chen6, J. Huang7, H. Hong8, G. Lin9, X. Li10, Y. Huang11, L. Song11

Author affiliations

  • 1 Department Of Respiratory, Shanghai Chest Hospital, 200030 - Shanghai/CN
  • 2 Department Of Respiratory, Shanghai Chest Hospital, 20030 - Shanghai/CN
  • 3 Department Of Oncology, The Second Affiliated Hospital of Nanchang University, 330006 - Nanchang/CN
  • 4 Department Of Breast Disease, Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, 450008 - Zhengzhou/CN
  • 5 General Medicine Department, Beijing Chest Hospital, Capital Medical University, 101149 - Beijing/CN
  • 6 Department Of Oncology, The First Affiliated Hospital of Soochow University, 215000 - Suzhou/CN
  • 7 Department Of Radiation Oncology, Guangxi Medical University Cancer Hospital, 530022 - Nanning/CN
  • 8 Department Of Medical Oncology, Sichuan Cancer Hospital, 610000 - Chengdu/CN
  • 9 Department Of Oncology, Fujian Cancer Hospital, 350014 - Fuzhou/CN
  • 10 Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd, 201210 - Shanghai/CN
  • 11 Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd, 200120 - Shanghai/CN

Resources

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Abstract 649P

Background

Nectin-4 is a cell adhesion molecule that serves as an attractive therapeutic target for ADCs, due to its high expression in a variety of solid tumors. SHR-A2102 is a novel ADC comprised of a fully humanized IgG1 mAb against nectin-4, a cleavable linker, and a topoisomerase I inhibitor payload. Here we present results of the dose escalation (D-ESC) and dose expansion (D-EXP) parts of a phase 1 study of SHR-A2102 for treating solid tumors.

Methods

Patients (pts) with nectin-4 positive, locally advanced unresectable or metastatic solid tumors, who had failed or were intolerant to standard therapies or had no standard treatment, were given SHR-A2102 intravenously Q3W. Primary objectives were to assess safety and tolerability.

Results

As of Apr 9, 2024, 38 pts were enrolled (median age: 61 yrs; ≥3 lines of prior therapies: 60.5%; prior ICI: 78.9%). During D-ESC, 17 pts received SHR-A2102 at 2 to 10 mg/kg. Only 1 pt in the 10 mg/kg group experienced a DLT (grade 4 decreased platelet count), and MTD was not yet reached. During D-EXP, additional 10 and 11 pts were given SHR-A2102 at 6 and 8 mg/kg, respectively. Overall, grade 3/4 TRAEs occurred in 42.1% (16/38) of pts, with the most common (≥10%) being decreased WBC count (21.1%), anemia (18.4%), decreased neutrophil count (15.8%), and decreased lymphocyte count (13.2%). No treatment-related deaths occurred. Among 30 pts evaluable for tumor response, ORR was 23.3% and DCR was 76.7% (Table). In 16 heavily pretreated NSCLC pts evaluable for tumor response, ORR was 31.3% (non-sq, 50.0%; sq, 12.5%) and DCR was 87.5% (non-sq, 75.0%; sq, 100.0%; Table). Table: 649P

Anti-tumor activity

Non-sq NSCLC (N=8) Sq NSCLC (N=8) All NSCLC (N=16) All tumor types (N=30)
Best overall response, n (%)
PR 4 (50.0) 1 (12.5) 5 (31.3) 7 (23.3)
SD 2 (25.0) 7 (87.5) 9 (56.3) 16 (53.3)
PD 2 (25.0) 0 2 (12.5) 7 (23.3)
ORR, % (95% CI) 50.0 (15.7–84.3) 12.5 (0.3–52.7) 31.3 (11.0–58.7) 23.3 (9.9–42.3)
DCR, % (95% CI) 75.0 (34.9–96.8) 100.0 (63.1–100.0) 87.5 (61.7–98.5) 76.7 (57.7–90.1)

Non-sq, non-squamous; sq, squamous.

Conclusions

SHR-A2102 showed a manageable safety profile and promising anti-tumor activity. Indication-specific cohorts are being recruited during the efficacy expansion part.

Clinical trial identification

NCT05701709; Release date: Jan 27, 2023.

Editorial acknowledgement

Legal entity responsible for the study

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Funding

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Disclosure

X. Li, Y. Huang, L. Song: Financial Interests, Personal, Full or part-time Employment: Jiangsu Hengrui Pharmaceuticals. All other authors have declared no conflicts of interest.

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