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anbenitamab repodatecan (JSKN003)
i
Other names: JSKN003, JSKN 003, JSKN-003
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Company:
Alphamab, CSPC Pharma
Drug class:
Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate
Related drugs:
1m
Clinical Study on Pathological Remission and Safety of JSKN003 Combined with KN046 New Adjuvant Therapy for muscle-invasive bladder cancer (ChiCTR2500109757)
P=N/A, N=20, Recruiting, harbin medical university cancer hospital; harbin medical university cancer hospital
New trial
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erfonrilimab (KN046) • anbenitamab repodatecan (JSKN003)
3ms
JSKN003-102: Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=725, Active, not recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2024 --> Dec 2025
Enrollment closed • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 expression • HER-2 positive + HER-2 overexpression
|
anbenitamab repodatecan (JSKN003)
3ms
JSKN003-302: JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects (clinicaltrials.gov)
P3, N=400, Recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Not yet recruiting --> Recruiting | Trial primary completion date: Apr 2025 --> Apr 2026
Enrollment open • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
gemcitabine • paclitaxel • docetaxel • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • vinorelbine tartrate • anbenitamab repodatecan (JSKN003)
3ms
FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov)
P2, N=716, Recruiting, Fudan University | Trial completion date: Sep 2025 --> Sep 2028 | Trial primary completion date: Dec 2024 --> Dec 2026
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • FOXC1 (Forkhead Box C1)
|
Herceptin (trastuzumab) • carboplatin • Focus V (anlotinib) • Perjeta (pertuzumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • Andewei (benmelstobart) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • Yidafan (ivonescimab) • AiRuiLi (adebrelimab) • SHR-4602 • TQB2102 • TQB2868 • anbenitamab repodatecan (JSKN003) • tizetatug rezetecan (SHR-A1921)
3ms
JSKN003-101: First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors (clinicaltrials.gov)
P1, N=62, Completed, Alphamab (Australia) Co Pty Ltd. | Recruiting --> Completed | N=45 --> 62 | Trial completion date: Dec 2024 --> Apr 2025 | Trial primary completion date: Oct 2024 --> Apr 2025
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 expression
|
anbenitamab repodatecan (JSKN003)
5ms
A biparatopic HER2-targeting ADC constructed via site-specific glycan conjugation exhibits superior stability, safety, and efficacy. (PubMed, RSC Chem Biol)
JSKN003 retained its cytotoxic activity against trastuzumab-resistant cells, attributed to efficient payload delivery and blockade of downstream HER2 signaling pathways, demonstrating the potential to overcome clinical trastuzumab resistance. JSKN003 demonstrated excellent antitumor activity and a favorable safety profile in clinical trials, highlighting its potential as a promising therapeutic option for patients with HER2-positive tumors. These findings suggest that JSKN003 could be a valuable therapeutic strategy with excellent efficacy and safety for HER2-expressing tumors in the clinical setting.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 overexpression • HER-2 positive + HER-2 overexpression
|
Herceptin (trastuzumab) • anbenitamab repodatecan (JSKN003)
6ms
JSKN003 Combined Treatment of HER2-positive Gastric Cancer (clinicaltrials.gov)
P2, N=153, Not yet recruiting, Shanghai JMT-Bio Inc.
New P2 trial
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Herceptin (trastuzumab) • capecitabine • oxaliplatin • anbenitamab (KN026) • Enshuxing (enlonstobart) • anbenitamab repodatecan (JSKN003)
9ms
JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer (clinicaltrials.gov)
P3, N=228, Recruiting, Shanghai JMT-Bio Inc. | Not yet recruiting --> Recruiting
Enrollment open
|
Kadcyla (ado-trastuzumab emtansine) • anbenitamab repodatecan (JSKN003)
9ms
JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer (clinicaltrials.gov)
P3, N=228, Not yet recruiting, Shanghai JMT-Bio Inc.
New P3 trial
|
Kadcyla (ado-trastuzumab emtansine) • anbenitamab repodatecan (JSKN003)
11ms
JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer (clinicaltrials.gov)
P3, N=430, Not yet recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd
New P3 trial
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paclitaxel • doxorubicin hydrochloride • topotecan • anbenitamab repodatecan (JSKN003)
11ms
JSKN003-102: Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=725, Recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | N=300 --> 725 | Trial completion date: Dec 2025 --> Dec 2026
Enrollment change • Trial completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 expression • HER-2 positive + HER-2 overexpression
|
anbenitamab repodatecan (JSKN003)
11ms
JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer (clinicaltrials.gov)
P3, N=430, Not yet recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd
New P3 trial
|
paclitaxel • doxorubicin hydrochloride • topotecan • anbenitamab repodatecan (JSKN003)
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