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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

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

NCT number NCT05620134
Study type Interventional
Source Salubris Biotherapeutics Inc
Contact Naimish Pandya, MD
Phone 301-969-8650
Email naimish.pandya@salubrisbio.com
Status Recruiting
Phase Phase 1/Phase 2
Start date October 17, 2022
Completion date February 20, 2026

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