Phase 01 Study of 177Lu-RAD202 to Assess Safety and Recommended Dose in Adults with HER2-Positive or HER2-Low Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating 177Lu-RAD202, a radiolabeled antibody targeting HER2, in a first-in-human, Phase 01 open-label study for patients with advanced solid tumors expressing HER2. The study aims to find the recommended doses for future research by assessing safety, tolerability, imaging quality, and dosimetry. Participants have tumors that are relapsed, refractory, or metastatic and have shown progression after prior therapies. The study includes a Screening Period lasting up to 4 weeks, followed by Phase 0 Imaging Period where a low dose of 177Lu-RAD202 is given to assess imaging and safety over about 2 weeks. After imaging assessments, the dose may be increased if needed. Then, in Phase 1 Treatment Period, participants receive escalating doses of 177Lu-RAD202 treatment in 6-week cycles. Multiple cycles may be given if clinical benefit is observed and safety is maintained. Dose-limiting toxicity is monitored for 6 weeks after the first treatment dose. During the study, participants undergo evaluations including imaging scans, safety assessments, and pharmacokinetic measurements over periods of up to 6 weeks or more. Researchers measure radiation dosimetry, treatment safety, tolerability, and preliminary antitumor activity. Participants may continue treatment cycles as long as benefits are seen and safety allows. The total duration of involvement varies depending on treatment response and monitoring needs.

HEAT Trial (HER2 Antibody Therapy With Lutetium-177)