A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer

Official Title

A Multi-Centre Open Label Dose Escalation and Dose Expansion Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and GEJ Cancer

Summary:

This is a Phase 1/2 multi-centre, 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 2 cycles (12 weeks per cycle) of study drug, and a 12-month Long-Term Follow-Up Period.

Trial Description

Primary Outcome:

• Proportion of patients achieving an objective response (CR or PR) with the use of CAM-H2 as measured by the RECIST version 1.1
• Clinical benefit rate (CBR) of CAM-H2 using the equation CBR = CR + PR + SD, as measured by the RECIST version 1.1

• Progression Free Survival (PFS) for patients receiving CAM-H2
• Duration of response (DoR) in patients receiving CAM-H2
• CBR in brain in patients receiving CAM-H2, using RANO-BM
• PFS in patients with brain metastases receiving CAM-H2
• Overall survival (OS) for patients receiving CAM-H2
• Proportion of patients on CAM-H2 who develop anti-drug antibodies (ADAs)

View this trial on ClinicalTrials.gov