NCT06667960

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

A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK06, a 5T4 Antibody Drug Conjugate, in Patients With Unresectable Locally Advanced or Metastatic Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 255 (estimated)
• Sponsor: Salubris Biotherapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered JK06 in patients with unresectable locally, advanced or metastatic cancer.

Detailed description

This Phase 1/2, open label, dose escalation and cohort expansion study is designed to evaluate and characterize the safety, tolerability, PK, immunogenicity, and preliminary anti-tumor activity of JK06 administered intravenously (IV) in patients with unresectable, locally advanced, or metastatic cancer. The study consists of a Dose Escalation phase to determine the MTD/recommended phase 2 dose (RP2D) of JK06, followed by a Cohort Expansion phase to further define the safety and initial efficacy of JK06 in tumor specific cohorts.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	JK06	Biparatopic anti-5T4 antibody

Timeline

• Start date: 2024-10-23
• Primary completion: 2028-04-01
• Completion: 2028-08-01
• First posted: 2024-10-31
• Last updated: 2026-03-05

Locations

14 sites across 2 countries: Belgium, Spain