Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer
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
2 other identifiers
interventional
263
2 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 cancer
Started Oct 2022
Typical duration for phase_1 cancer
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2022
CompletedFirst Submitted
Initial submission to the registry
November 3, 2022
CompletedFirst Posted
Study publicly available on registry
November 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2026
CompletedOctober 15, 2024
October 1, 2024
3 years
November 3, 2022
October 11, 2024
Conditions
Outcome Measures
Primary Outcomes (5)
Dose-limiting Toxicity (DLT)
The incidence of DLTs during the DLT assessment period.
First 21 days of treatment.
Dose-Finding
Determination of the maximum-tolerated dose/recommended Phase 2 dose.
Screening to 90 days from last dose.
Safety and Tolerability
Incidence, nature, and severity of treatment-emergent adverse events \[TEAEs\]. Defined as any AE that occurs during the treatment period (i.e., after any treatment) and up to 28 days after the last dose of study treatment.
First treatment through 28 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
Safety and Tolerability
Incidence, nature, and severity of Serious Adverse Events \[SAEs\].
Screening date through 30 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
Safety and Tolerability
Incidence, nature, and severity of adverse events \[AEs\].
Screening date through 30 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
Secondary Outcomes (6)
Pharmacokinetics of JK08
Day 1 of dosing through 21 days post last dose.
Pharmacokinetics of JK08
Day 1 of dosing through 21 days post last dose.
Objective Response Rate (ORR)
Day 1 of dosing through every 90 after the last dose.
Disease Control Rate (DCR)
ay 1 of dosing through every 90 after the last dose.
Progression Free Survival (PFS)
Day 1 of dosing through every 90 after the last dose.
- +1 more secondary outcomes
Study Arms (4)
Dose Escalation
EXPERIMENTALEscalating repeated doses of JK08 administered as a subcutaneous injection. A cycle of treatment is defined as 21 days, in which three doses of JK08 will be planned for administration.
Dose Expansion Pembrolizumab Combination Cohort - Non-Small Cell Lung Cancer
EXPERIMENTALJK08 administered at the maximum-tolerated dose/recommended Phase 2 dose as a subcutaneous injection in patients with a mix of solid tumors. Pembrolizumab will be given IV per standard institutional practice
Dose Expansion Pembrolizumab Combination Cohort - Colorectal Cancer
EXPERIMENTALJK08 administered at the maximum-tolerated dose/recommended Phase 2 dose as a subcutaneous injection in patients with a mix of solid tumors. Pembrolizumab will be given IV per standard institutional practice
Dose Expansion Lenvatinib Combination Cohort - Hepatocellular Cancer
EXPERIMENTALJK08 administered at the maximum-tolerated dose/recommended Phase 2 dose as a subcutaneous injection in patients with a mix of solid tumors. Lenvatinib will be given orally per standard institutional practice
Interventions
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.
Immune checkpoint inhibitor
Multi-kinase inhibitor
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years old.
- Signed informed consent and willing and able to comply with study procedures and scheduled visits.
- For Dose Escalation, patients with one of the following histologically diagnosed unresectable, locally advanced, or metastatic tumor types:
- 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).
- +39 more criteria
You may not qualify if:
- Patients with symptomatic or unstable CNS primary tumor or metastases and/or carcinomatous meningitis. Patients with documented treated CNS metastases stable for at least 4 weeks may be enrolled at the discretion of the investigator.
- Patients with active, or history of, severe autoimmune disease who in the opinion of the investigator and/or the Sponsor or Sponsor's designee would be exposed to unacceptable risk by participating in the study.
- Major surgery within 6 weeks from treatment initiation.
- Clinically significant cardiovascular/vascular disease ≤ 6 months before first dose:
- Myocardial infarction or unstable angina.
- Clinically significant cardiac arrhythmias.
- Uncontrolled hypertension: systolic blood pressure (SBP) \> 180 mmHg, diastolic blood pressure (DBP) \> 100 mmHg.
- Pulmonary embolism, symptomatic cerebrovascular events or any other serious cardiac condition (e.g., pericardial effusion or restrictive cardiomyopathy).
- QTcF prolongation \> 480 msec.
- Congestive heart failure (New York Heart Association class III-IV).
- Myocarditis/clinically significant pericarditis.
- Clinically significant gastrointestinal disorders including:
- Gastrointestinal perforation or unhealed ulcerations \< 6 months prior to study drug administration. Patients must have documented evidence (e.g., upper endoscopy, colonoscopy) of completely healed area of prior perforation.
- Clinically significant gastrointestinal bleeding \< 3 months prior to study drug administration.
- Pancreatitis \< 6 months prior to study drug administration.
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Institut Jules Bordet
Brussels, 1070, Belgium
UZA
Edegem, Belgium
UZ Ghent
Ghent, 9000, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2022
First Posted
November 17, 2022
Study Start
October 17, 2022
Primary Completion
October 17, 2025
Study Completion
February 20, 2026
Last Updated
October 15, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share