The trial aims to evaluate the drug’s safety, tolerability and optimal dosing in patients with select advanced solid tumours. Credit: Peddalanka Ramesh Babu / Shutterstock.

China’s National Medical Products Administration (NMPA) has approved an investigational new drug (IND) application from Adcentrx Therapeutics to begin a Phase Ia/Ib study of ADRX-0706, a drug targeting advanced solid tumours.

The approval allows China-based clinical centres to be included in the ongoing study, marking a significant expansion of the trial’s geographical scope.

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The first-in-human, open-label Phase Ia/Ib trial aims to evaluate the safety, tolerability and optimal dosing of ADRX-0706 in patients with select advanced solid tumours.

Characterising the drug’s safety profile and determining the most suitable dose for further studies are the trial’s primary objectives.

In the two-part study, the Phase Ia dose escalation segment will initially assess the safety and tolerability of ADRX-0706, as well as identify the recommended dose for the subsequent Phase Ib.

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Phase Ib will continue to evaluate the drug’s safety, tolerability and preliminary efficacy in three disease-specific expansion cohorts to establish the best dose of ADRX-0706.

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Adcentrx anticipates an initial data readout by the middle of this year.

ADRX-0706 is an antibody-drug conjugate (ADC) consisting of a fully human IgG1 antibody targeting human Nectin-4.

It is linked to a tubulin inhibitor payload, AP052, through Adcentrx’s i-Conjugation technology, which employs a cleavable linker and stable conjugation chemistry.

Adcentrx Therapeutics founder and CEO Hui Li said: “NMPA’s clearance of the ADRX-0706 IND is an important milestone for Adcentrx.

“We now have the ability to recruit patients in both the US and China to generate valuable data in different patient populations, and the data will enable us to further explore ADRX-0706 in treating patients with high unmet needs across multiple tumour types.”

In October 2023, Li told Clinical Trials Arena that Adcentrx was actively evaluating options to open international sites in its ongoing Phase Ia/Ib trial investigating ADRX-0706 in advanced solid tumours.