AK146D1 / Akesobio - LARVOL DELTA

Akeso, Inc…announced today that it has received clearance from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) to initiate Phase II clinical trials for AK146D1, a first-in-class Trop2 /Nectin4 bispecific antibody-drug conjugate (ADC), and AK138D1, an innovative HER3-targeting ADC. (The Manila Times) - "The studies will evaluate these two novel ADC candidates in combination with the Company's pioneering immuno-oncology (IO) 2.0 bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), as well as other proprietary high-potential anti-tumor assets, including AK117 (anti-CD47 monoclonal antibody) and AK109 (anti-VEGF monoclonal antibody), across a spectrum of advanced solid tumors....These Phase II studies will leverage the cadonilimab and ivonescimab as foundational backbone therapies, capitalizing on their validated clinical profiles in checkpoint blockades and dual VEGF/PD-1 inhibition."

New P2 trial • Solid Tumor

A Study of AK146D1 for Injection in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Study of AK146D1 for Injection in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Study of AK146D1 for Injection in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=200 | Not yet recruiting | Sponsor: Akeso

New P1 trial • Oncology • Solid Tumor

Akeso's First Bispecific ADC (Trop2/Nectin4 ADC) Enters Clinical Trials, Strengthening Leadership in 'IO+ADC' 2.0 Strategy (PRNewswire) - "Akeso...has announced the successful enrollment of the first patient in its Phase Ia clinical trial for AK146D1, a bispecific Antibody-Drug Conjugate (ADC) targeting Trop2 and Nectin4. AK146D1 is Akeso's first bispecific ADC to enter clinical trials. AK146D1 has recently received approval from the U.S. FDA, Australia's TGA, and China's NMPA to begin clinical trials."

Trial status • Solid Tumor

A Study of AK146D1 for Injection in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Akeso

New P1 trial • Oncology • Solid Tumor