BsADCs are a transformative therapeutic modality for breast cancer. Their ability to enhance tumor selectivity, overcome heterogeneity, and target resistant pathways positions them as key players in the future oncology landscape, with ongoing trials poised to define their clinical role.

11 days ago

Review • Journal

EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)

HER-2 expression

zanidatamab zovodotin (ZW49) • izalontamab brengitecan (BL-B01D1) • anbenitamab repodatecan (JSKN003)

3ms

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

3 months ago

New trial

erfonrilimab (KN046) • anbenitamab repodatecan (JSKN003)

5ms

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

5 months ago

Enrollment closed • Trial primary 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)

5ms

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

5 months ago

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)

6ms

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

6 months ago

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)

6ms

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

6 months ago

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)

7ms

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.

7 months ago

Journal

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)

8ms

JSKN003 Combined Treatment of HER2-positive Gastric Cancer (clinicaltrials.gov)

P2, N=153, Not yet recruiting, Shanghai JMT-Bio Inc.

8 months ago

New P2 trial

Herceptin (trastuzumab) • capecitabine • oxaliplatin • anbenitamab (KN026) • Enshuxing (enlonstobart) • anbenitamab repodatecan (JSKN003)

11ms

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

11 months ago

Enrollment open

Kadcyla (ado-trastuzumab emtansine) • anbenitamab repodatecan (JSKN003)

11ms

JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer (clinicaltrials.gov)

P3, N=228, Not yet recruiting, Shanghai JMT-Bio Inc.

11 months ago

New P3 trial

Kadcyla (ado-trastuzumab emtansine) • anbenitamab repodatecan (JSKN003)

1year

JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer (clinicaltrials.gov)

P3, N=430, Not yet recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd

1 year ago

New P3 trial

paclitaxel • doxorubicin hydrochloride • topotecan • anbenitamab repodatecan (JSKN003)