Phase 12 Study of JK06 Antibody Drug Conjugate Given Intravenously in Adults with Unresectable Locally Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating JK06, a biparatopic anti-5T4 antibody drug conjugate, in patients with unresectable locally advanced or metastatic solid tumors. This Phase 12, open-label study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and initial anti-tumor activity of JK06. The study includes dose escalation to find the maximum tolerated dose and recommended Phase 2 dose, followed by dose expansion in specific tumor groups to further evaluate safety and early efficacy. Participants receive JK06 intravenously in cycles of 21 days. The dose escalation phase involves increasing doses to identify the optimal dose, while the cohort expansion phase uses this dose to treat tumor-specific groups. The study is randomized without masking and includes multiple centers. Treatment continues through these phases to collect detailed safety and response data. During the study, participants will have regular assessments including tumor measurement by CT or MRI scans, laboratory tests to monitor blood counts and organ function, and evaluations of adverse events. Researchers will track dose-limiting toxicities, pharmacokinetics, immune response, and tumor response over up to 104 weeks. Participants are monitored for safety up to 28 days after the last dose, and long-term outcomes such as progression-free survival and duration of response are also recorded.

Study of JK06 in Patients With Unresectable Locally Advanced or Metastatic Cancer