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JSKN003

DRUG8 trials

Sponsors

Alphamab (Australia) Co Pty Ltd., Fudan University, Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Shanghai JMT-Bio Inc.

Conditions

Advanced Solid TumorAdvanced Solid TumorsBreast CancerBreast NeoplasmBreast TumorsEarly-stage Breast CancerFallopian Tube CancersHER2-negative Breast Cancer

Phase 1

First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors
CompletedNCT05494918
Alphamab (Australia) Co Pty Ltd.Advanced Solid Tumors, Metastatic Solid Tumors
Start: 2022-09-02End: 2025-04-15Updated: 2025-08-22
Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors
Active, not recruitingNCT05744427
Jiangsu Alphamab Biopharmaceuticals Co., LtdAdvanced Solid Tumor
Start: 2023-03-15End: 2026-12-31Target: 725Updated: 2026-02-02

Phase 2

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
RecruitingNCT05582499
Fudan UniversityBreast Cancer, Breast Neoplasm, Breast Tumors +7
Start: 2022-11-01End: 2028-09-30Target: 716Updated: 2025-08-22
JSKN003 Combined Treatment of HER2-positive Gastric Cancer
Not yet recruitingNCT06998771
Shanghai JMT-Bio Inc.HER2-positive Gastric Cancer
Start: 2025-06-15End: 2029-12-31Target: 153Updated: 2025-05-31

Phase 3

JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
RecruitingNCT06079983
Jiangsu Alphamab Biopharmaceuticals Co., LtdBreast Cancer
Start: 2023-12-01End: 2029-03-01Target: 400Updated: 2025-09-12
JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer
Not yet recruitingNCT06751485
Jiangsu Alphamab Biopharmaceuticals Co., LtdFallopian Tube Cancers, Ovarian Cancer, Primary Peritoneal
Start: 2025-01-15End: 2027-12-30Target: 430Updated: 2024-12-31
JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer
RecruitingNCT06846437
Shanghai JMT-Bio Inc.Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants
Start: 2025-02-18End: 2028-12-31Target: 228Updated: 2025-03-24
JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan
Not yet recruitingNCT07384377
Shanghai JMT-Bio Inc.HER2-positive Colorectal Cancer
Start: 2026-02-06End: 2028-06-15Target: 123Updated: 2026-02-03

Related Papers

Abstract GS1-04: HER2-Directed Antibody-Drug Conjugate SHR-A1811 in the Neoadjuvant Treatment of HER2-positive Early Breast Cancer: a Prospective, Randomized, Open-label, Phase 2 Trial
Clinical Cancer Research2025-06-13
Abstract P2-11-06: Neoadjuvant chemotherapy plus camrelizumab vs. chemotherapy in patients with locally advanced immunomodulatory triple-negative breast cancer: a prospective, randomized, open-label, phase 2 trial
Clinical Cancer Research2025-06-13
JSKN003, a biparatopic HER2-targeting ADC, in heavily pretreated HER2-positive breast cancer: A pooled analysis of early-phase studies.
Journal of Clinical Oncology2025-05-282 citations
A pooled analysis of JSKN003, a biparatopic anti-HER2 antibody conjugate (ADC), in patients with advanced HER2-overexpressing (IHC 3+) gastrointestinal tumors.
Journal of Clinical Oncology2025-05-282 citations
JSKN003, a biparatopic anti-HER2 antibody drug conjugate (ADC), in the treatment of platinum-resistant ovarian cancer (PROC): Updated findings from two clinical trials.
Journal of Clinical Oncology2025-05-281 citations
Safety and efficacy of JSKN003 in patients with advanced/metastatic solid tumors: A first-in-human, dose-escalation, multicenter, open-label, phase I study.
Journal of Clinical Oncology2024-06-017 citations
Evaluation of the safety, pharmacokinetics, and efficacy of JSKN003 in patients with advanced solid tumors: A phase I/II clinical study.
Journal of Clinical Oncology2024-06-015 citations
Abstract CT179: Safety and efficacy of JSKN003 in patients with advanced/metastatic solid tumors: A first-in-human, dose-escalation, multicenter, open-label, phase I study
Cancer Research2024-04-054 citations
Rational and trial design of FASCINATE-N: a prospective, randomized, precision-based umbrella trial
Therapeutic Advances in Medical Oncology2024-01-017 citations
JSKN003, A NOVEL BIPARATOPIC ANTI-HER2 ANTIBODY-DRUG CONJUGATE, EXHIBITS POTENT ANTITUMOR EFFICACY
Antibody Therapeutics2023-07-017 citations