On April 2, 2026 CanWell Pharma Inc. reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CAN016, a HER2-targeting dual-payload ADC. The company will initiate a Phase I clinical study to evaluate CAN016 in solid tumor patients who have experienced disease progression following prior ADC therapies.

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About CAN016

CAN016 is an ADC in development by CanWell Pharma Inc. for ADC pre-treated solid tumors. Developed using CanWell’s StarLinker platform, CAN016 is distinguished by its integration of two distinct MoA cytotoxic agents within a single antibody construct, leading to enhanced anti-tumor activity through complementary mechanisms. This design is expected to counter the resistance mechanisms that limit the efficacy of conventional single payload ADCs.

In preclinical studies, CAN016 effectively delivered dual cytotoxic payloads into tumor cells leading to synergistic tumor cell killing, inhibition of proliferation, and apoptosis. CAN016 has demonstrated potent anti-tumor activity in multiple CDX and PDX models, including those resistant to currently approved HER2-targeted ADC therapies.

The Phase I study will assess the safety, tolerability, and pharmacokinetics of CAN016, determine the recommended dose for subsequent clinical development, and explore preliminary anti-tumor efficacy across a range of HER2-expressing ADC pre-treated solid tumors.

(Press release, Canwell Pharma, APR 2, 2026, View Source [SID1234664161])