NCT05620134

Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer

A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK08, an IL-15 Antibody Fusion Protein Targeting CTLA-4, Monotherapy or in Combination in Patients with Unresectable Locally Advanced or Metastatic Cancer

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 263 (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 subcutaneously administered JK08 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, pharmacodynamics, immunogenicity, and preliminary antitumor activity of JK08 administered subcutaneously (SC) on a once weekly (QW) schedule in patients with unresectable locally, advanced or metastatic cancer. The study consists of a Dose Escalation phase to determine the MTD/OBD of JK08, followed by a Cohort Expansion phase to further define the safety and initial efficacy of JK08 monotherapy or in combinations.

Conditions

• Cancer
• Tumor, Solid
• Advanced Solid Tumor
• Metastatic Cancer
• Melanoma
• Colorectal Cancer
• Non-small Cell Lung Cancer
• Small-cell Lung Cancer
• Urothelial Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Luminal Breast Cancer
• Triple Negative Breast Cancer
• Clear Cell Renal Cell Carcinoma
• Papillary Renal Cell Carcinoma
• Gastric Adenocarcinoma
• GastroEsophageal Cancer
• Squamous Cell Carcinoma Skin
• Pancreatic Adenocarcinoma
• Hepatocellular Carcinoma
• Colorectal Adenocarcinoma
• Epithelial Ovarian Cancer
• Thyroid Cancer

Interventions

Type	Name	Description
DRUG	JK08	Recombinant fusion protein consisting of two functional elements, which are a fully human monoclonal antibody, directed against CTLA-4 and a protein complex formed by the human IL-15 and the Sushi domain of human IL-15Rα.
DRUG	Pembrolizumab	Immune checkpoint inhibitor
DRUG	Lenvatinib Pill	Multi-kinase inhibitor

Timeline

• Start date: 2022-10-17
• Primary completion: 2025-10-17
• Completion: 2026-02-20
• First posted: 2022-11-17
• Last updated: 2024-10-15

Locations

11 sites across 2 countries: Belgium, Spain