ClinicalTrials.gov ID NCT04467515
Sponsor Precirix
Local PI Rebecca Wong
Conditions
- Advanced/Metastatic HER2-positive Breast
- Gastric
- Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care Treatment
This is a Phase 1/2 multi-center, open label, dose escalation and dose expansion study to evaluate safety, tolerability, dosimetry, pharmacodynamics (PD), and efficacy of the targeted radionuclide therapeutic CAM-H2 in patients with progressive, advanced/metastatic HER2-positive breast, gastric, and GEJ cancer with disease progression following anti-HER2 standard of care treatment. The study duration for each phase will be up to 18 months. The study is comprised of a Treatment Period, consisting of a maximum of 4 cycles (12 weeks per cycle) of study drug, and a 12-month Long-Term Follow-Up Period.