A study of JK08 in patients with unresectable locally advanced cancer

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The company Salubris Biotherapeutics Inc is commencing recruitment for the clinical trial of JK08, an IL-15 Antibody Fusion Protein Targeting CTLA-4, in Patients With Unresectable Locally Advanced or Metastatic Cancer (solid tumor, advanced solid tumor, metastatic cancer, melanoma, colorectal cancer, breast cancer). The study takes place in Belgium.

The trial officially began on the October 17, 2022 and is planned to complete on February 20, 2026. 

This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study.

The population that can be enrolled into this study includes:

- Non-small cell lung cancer (NSCLC). - Small cell lung cancer (SCLC). - Melanoma. - Clear cell or papillary renal cell carcinoma (RCC). - Urothelial cancer (UC). - Head and neck squamous cell cancer (HNSCC). - Luminal B (ER+, PR-, any HER2 status) or triple-negative breast cancer. - Gastric or gastro esophageal adenocarcinoma (GC/GEJ). - Esophageal squamous cell cancer. - Skin squamous cell carcinoma (SCC). - Pancreatic adenocarcinoma. - Hepatocellular carcinoma (Childs-Pugh A or B7 only). - Colorectal adenocarcinoma (CRC). - Epithelial ovarian cancer. - Cervical cancer. - Endometrial adenocarcinoma. - Thyroid cancer (follicular or papillary). For the escalation cohorts, patients must have experienced progressive disease on or be intolerant to an established standard systemic anti-cancer therapy for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds. Patients must have no available proven curative or life prolonging therapies. 

For the detailed inclusion and exclusion criteria, as well as to see the site location and address, please see the study profile: https://ichgcp.net/clinical-trials-registry/NCT05620134.

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