JK08.1.01
Research type
Research Study
Full 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
IRAS ID
1007861
Contact name
Naimish Pandya
Contact email
Sponsor organisation
Salubris Biotherapeutics, Inc.
Eudract number
2022-000339-21
Research summary
The JK08 study will be conducted in 2 phases:
• Dose Escalation phase to determine the maximum tolerated (MTD) of JK08 administered subcutaneously weekly in a 3-week cycle until disease progression, unmanageable toxicity, withdrawal of consent or study termination.
• Already enrolling in Spain and Belgium into Cohort 7 (300 ug/kg).
• Cycle 1 in each patient is the “Dose Limiting Toxicity (DLT) evaluable period” after which the Safety Research Committee (SRC) will review the safety data at each dose level prior to dose escalation.
• Additional patients may be enrolled as part of a backfill cohort at the previous dose level to further evaluate safety and PK/PD at that level (max 12 patients/dose level).
• Fresh tumour biopsies are mandatory for backfill patients.
• MTD will be defined as the dose level below the level that is associated with DLT(s) in two out of three patients or two out of six patients. The JK08 dose in dose expansion cohorts may be the MTD or a dose regarded as the Optimal Biologic Dose (OBD) based on emerging safety/ tolerance and PK/PD data.
• Cohort Expansion phase to further define the safety and initial efficacy of JK08 in tumor specific cohorts, alone and in combination with standard therapy. Patients with specific tumor types will be treated at OBD to further characterize the safety, tolerability, PK/PD and anti-tumour activity of JK08.
• Monotherapy: 4 cohorts – HPV+ve, melanoma, cutaneous squamous cell cancer) and a basket cohort of mixed solid tumours. Mandatory biopsies for 6 patients in each cohort (except Basket cohort).
• Pembrolizumab: 3 cohorts – Non small cell lung cancer, colorectal cancer and breast cancer.
• Lenvatinib: 1 cohort – hepatocellular cancer.
• Safety follow-up (FU) for 28 days then every 3 months until disease progression or start of alternate anti-cancer systemic treatment.
• Survival FU every 3 months (email/phone) for at least 1 year.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
24/YH/0079
Date of REC Opinion
23 May 2024
REC opinion
Further Information Favourable Opinion