Clinical Trials Logo

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

See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients