Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer
NCT05620134 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 263
Last updated 2024-10-15
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.
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
- 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
-
Immune checkpoint inhibitor
- DRUG
-
Lenvatinib Pill
Multi-kinase inhibitor
Sponsors & Collaborators
-
Salubris Biotherapeutics Inc
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-17
- Primary Completion
- 2025-10-17
- Completion
- 2026-02-20
Countries
- Belgium
- Spain
Study Locations
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