CanWell Pharma Receives FDA Clearance for CAN016 ADC Trial

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CanWell Pharma announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CAN016, a HER2-targeting antibody-drug conjugate (ADC) with two distinct cytotoxic payloads. 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.

Why it matters

CAN016's dual-payload design is expected to overcome the resistance mechanisms that limit the efficacy of conventional single-payload ADCs, potentially providing a new treatment option for patients with HER2-expressing solid tumors who have failed prior ADC therapies.

The details

CAN016 is developed using CanWell's StarLinker platform and integrates two distinct mechanisms of action within a single antibody construct, leading to enhanced anti-tumor activity through complementary cytotoxic effects. In preclinical studies, CAN016 demonstrated potent anti-tumor activity in multiple cancer models, including those resistant to currently approved HER2-targeted ADC therapies.

• The FDA cleared the IND application for CAN016 on April 2, 2026.
• CanWell Pharma will initiate a Phase I clinical study to evaluate CAN016 in the near future.

What’s next

CanWell Pharma will initiate a Phase I clinical study to evaluate 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.