Akeso, Inc. (Hong Kong; HKEX: 9926.HK) announced on March 24, 2026, that it has received clearance from China's National Medical Products Administration to initiate Phase II clinical trials for AK146D1, a bispecific antibody-drug conjugate targeting Trop2 and Nectin4, and AK138D1, a HER3-targeting ADC, according to a company press release. The studies will evaluate these ADCs in combination with ivonescimab (PD-1/VEGF bispecific) and cadonilimab (PD-1/CTLA-4 bispecific) across advanced solid tumors. No numerical efficacy or safety data were reported. The company stated only that early-stage data for both AK146D1 and AK138D1 demonstrated "potent anti-tumor activity and a highly manageable safety profile," without disclosing response rates, survival endpoints, adverse event frequencies, dosing details, or the number of patients evaluated.
The Phase II studies will combine these ADCs with Akeso's bispecific checkpoint antibodies and other proprietary assets including AK117 (anti-CD47) and AK109 (anti-VEGF). The company did not disclose study design details, patient enrollment targets, primary endpoints, blinding status, or anticipated data readout timelines. Phase I trials for AK146D1 are currently recruiting in China and Australia, but no data from those studies have been publicly reported. The announcement is a regulatory clearance milestone, not a data readout; no Phase II results are available, and all characterizations of activity and safety are qualitative company statements without supporting numerical evidence.
AK146D1 is a bispecific ADC engineered to bind both Trop2 and Nectin4, antigens co-expressed in epithelial tumors including lung, breast, and bladder cancers. Approved single-target ADCs in this space include sacituzumab govitecan (Trop2-directed), which showed median progression-free survival of 5.6 months versus 1.7 months for chemotherapy in the Phase III ASCENT trial in metastatic triple-negative breast cancer, and enfortumab vedotin (Nectin4-directed), which demonstrated median overall survival of 12.88 months versus 8.97 months for chemotherapy in the Phase III EV-301 trial in advanced urothelial carcinoma. Cross-trial comparisons are limited by differences in study design, duration, and patient populations.
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