CAN016 / Canwell Biotech - LARVOL DELTA

CW-301 FIH Study of CAN016 (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: Canwell Biotech Limited | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

CW-301 FIH Study of CAN016 (clinicaltrials.gov) - P1/2 | N=90 | Not yet recruiting | Sponsor: Canwell Biotech Limited

First-in-human • New P1/2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

CAN016, a HER2-targeted dual-payload ADC, phase 1 clinical development (AACR 2026) - "Based on those findings, targeted monoclonal antibodies (such as Herceptin) and ADC (such as Enhertu) have been approved, expending the landscape of cancer therapy. CAN016 represents a promising therapeutic for HER2-positive/mutant solid tumors in preclinical study, particularly in the post-ADC setting. IND applications have been submitted to the US FDA and China CDE."

ADC • Clinical • P1 data • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

CanWell Pharma Announces FDA Clearance of the IND for CAN016, a Dual-Payload ADC Targeting HER2, for ADC Pre-Treated Solid Tumors (Businesswire) - "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."

IND • New P1 trial • Solid Tumor