Akeso received CDE clearance from China’s NMPA to start a Phase I trial of AK158D1, a bispecific ADC that targets EGFR and TROP2 in advanced solid tumours. The dual‑target design aims to improve tumour coverage and selectivity while delivering a cytotoxic payload. Preclinical results showed anti‑tumour activity and a favourable safety profile. AK158D1 is the company’s fourth ADC to enter the clinic as Akeso advances a broad oncology pipeline.
China Clears Akeso’s Dual‑Target ADC AK158D1 For Phase I Trial In Advanced Solid Tumours
Akeso continues to develop its bispecific antibody and ADC pipeline. Credit: Love Employee / Shutterstock.com.
Akeso has received clearance from the Center for Drug Evaluation (CDE) at China’s National Medical Products Administration (NMPA) to initiate a Phase I clinical trial of AK158D1, an investigational bispecific antibody–drug conjugate (ADC) for patients with advanced malignant solid tumours.
What AK158D1 Targets
AK158D1 is engineered to bind simultaneously to epidermal growth factor receptor (EGFR) and trophoblast cell surface antigen 2 (TROP2), two proteins that are frequently co‑expressed across a range of solid tumour types. By engaging both targets, the therapy aims to improve tumour coverage and increase tumour cell selectivity.
Why Dual Targeting Matters
Single‑target ADCs against EGFR or TROP2 have delivered clinical benefits but face challenges such as incomplete tumour targeting, off‑target toxicity and the emergence of multidrug resistance. AK158D1’s bispecific antibody backbone is designed to direct a cytotoxic payload more precisely to tumour cells that express either or both antigens, with the goal of enhancing anti‑tumour activity while improving the safety profile.
Preclinical Data and Development Context
Preclinical studies of AK158D1 reportedly demonstrated anti‑tumour efficacy and a favourable safety profile in relevant models. AK158D1 is Akeso’s fourth ADC to enter clinical development, following AK146D1, AK138D1 and AK157D1.
Broader Pipeline
Akeso continues to advance a broad biopharmaceutical pipeline that includes bispecific antibodies and ADCs. The company lists more than 50 R&D assets across oncology, inflammation, autoimmune and metabolic diseases, operates multiple research platforms, and has eight commercially available drugs. Two of its bispecific antibodies are already approved for cancer treatment.
Akeso is also developing agents such as ivonescimab and cadonilimab; earlier this month, ivonescimab (in partnership with Summit Therapeutics) reported a further overall survival benefit as a key secondary endpoint in a first‑line non‑small cell lung cancer (NSCLC) Phase III study.
Source: Originally published by Clinical Trials Arena, a GlobalData brand.
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