Spots Global Cancer Trial Database for Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer
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Trial Identification
Brief Title: Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer
Official Title: 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
Study ID: NCT05620134
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Institut Jules Bordet, Brussels, , Belgium
UZA, Edegem, , Belgium
UZ Ghent, Ghent, , Belgium
CHU UCL Namur - site Godinne, Yvoir, , Belgium
NEXT Oncology Barcelona, Barcelona, , Spain
Vall d Hebron Institute of Oncology VHIO, Barcelona, , Spain
Next Oncology Madrid Hospital Quironsalud Madrid, Madrid, , Spain
NEXT Oncology Madrid, Madrid, , Spain
START Madrid, Madrid, , Spain
University Hospital October 12, Madrid, , Spain
Instituto de Investigación Sanitaria INCLIVA, Valencia, , Spain
Contact Details
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