Alphamab-B (09966): Phase II Clinical Trial IND Application for JSKN033 Officially Accepted by CDE

Stock News2025-12-29

Alphamab-B (09966) announced that the Investigational New Drug (IND) application for a Phase II clinical trial (Study Number: JSKN033-202) of JSKN033 has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. JSKN033 is a high-concentration subcutaneous injection compound consisting of an anti-human epidermal growth factor receptor 2 (HER2) bispecific antibody-drug conjugate (ADC) and a programmed death-ligand 1 (PD-L1) immune checkpoint inhibitor. The trial will evaluate JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, as a first-line treatment for advanced cervical cancer.

JSKN033-202 is an open-label, multicenter, Phase II clinical study designed to assess the safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics of JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with advanced cervical cancer. All enrolled patients will receive treatment with JSKN033 combined with either cisplatin or carboplatin, with or without bevacizumab. The choice of platinum-based drug and the decision regarding concomitant use of bevacizumab will be determined by the investigator based on the individual patient's specific condition.

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