Alphamab Oncology Launches Groundbreaking Clinical Trial in Australia for Advanced Cancer Treatment

26 March 2024 | Tuesday | News

First patient dosed in innovative study of JSKN033, combining HER2 bispecific antibody-drug conjugate and PD-L1 antibody for solid tumors, promising enhanced efficacy and patient compliance with subcutaneous delivery
Image Source : Public Domain

Image Source : Public Domain

Alphamab Oncology (stock code: 9966.HK) announced that the first patient has been dosed in Australia in the clinical study (JSKN033-101) of JSKN033, a subcutaneous formulation with HER2 bispecific antibody-conjugated drug and PD-L1 monoclonal antibody, for the treatment of HER2-expressing, advanced or metastatic solid tumors.

Previous clinical studies have shown that combining antibody-drug conjugates (ADCs) with immunotherapy can enhance treatment efficacy and substantially prolong overall survival. However, this combination approach often leads to prolonged infusion and hospitalization durations, along with increased adverse events. The safety concern will be further exacerbated when chemotherapy regimens are included in the combo regimen. These factors can significantly impact patient medication compliance.

JSKN033, developed on top of the superior solubility and stability of Envaforlimab, is anticipated to offer a novel and effective treatment option for patients and healthcare providers by combining immune-oncology (IO) and ADC therapies. Notably, the nature of subcutaneous injectable will lead to improved safety and convenience. This innovative approach aims to mitigate the challenges associated with IV infusion, thereby enhancing patient adherence and treatment outcomes.

JSKN033-101 is an open-label, muti-center, phase I/II clinical study. The study consists of dose escalation and dose expansion phases: the Phase I dose escalation stage aims to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of JSKN033 in patients with advanced or metastatic HER2-expressing solid tumors, determining the maximum tolerated dose (MTD) and/or Phase II recommended dose (RP2D); the Phase II dose expansion stage will evaluate the efficacy and safety of JSKN033 in HER2-expressing gastrointestinal tumors at the RP2D dose.

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