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 intravenously administered JK06 in patients with unresectable locally, advanced or metastatic cancer.
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 anti-tumor activity of JK06 administered intravenously (IV) in patients with unresectable, locally advanced, or metastatic cancer. The study consists of a Dose Escalation phase to determine the MTD/recommended phase 2 dose (RP2D) of JK06, followed by a Cohort Expansion phase to further define the safety and initial efficacy of JK06 in tumor specific cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Biparatopic anti-5T4 antibody
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
RECRUITINGInstitut Jules Bordet
Brussels, Belgium
RECRUITINGUZ Ghent
Ghent, Belgium
Dose-limiting Toxicity (DLT)
The incidence of DLTs during the DLT assessment period.
Time frame: First 21 days of treatment.
Dose-Finding
Determination of the maximum-tolerated dose/recommended Phase 2 dose.
Time frame: From First Patient Dosed to end of Escalation, up to 14 months.
Incidence of Treatment-Emergent Adverse Events [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.
Time frame: First treatment through 28 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence, nature, and severity of Serious Adverse Events \[SAEs\].
Time frame: Screening date through 28 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
Pharmacokinetics of JK06
Maximum Plasma Concentration (Cmax)
Time frame: Day 1 of dosing through 7 days post last dose.
Pharmacokinetics of JK06
Area Under the Curve (AUC)
Time frame: Day 1 of dosing through 7 days post last dose.
Immunogenicity of JK06 by blood level measurement
Lab draws at protocol defined intervals to measure Immunogenicity of circulating anti drug antibodies (ADA)
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CHU UCL Namur - site Godinne
Yvoir, Belgium
RECRUITINGNEXT Oncology Barcelona
Barcelona, Spain
RECRUITINGVall d Hebron Institute of Oncology VHIO
Barcelona, Spain
RECRUITINGNext Oncology Madrid
Madrid, Spain
RECRUITINGSTART Madrid
Madrid, Spain
RECRUITINGTime frame: Day 1 of dosing through 7 days post last dose.
Objective Response Rate (ORR)
ORR according to RECIST v1.1.
Time frame: From date of randomization until the date of first documented progression, assessed up to 104 weeks
Disease Control Rate (DCR)
The percentage of patients with a complete response, partial response, or stable disease for at least 2 consecutive tumor assessments.
Time frame: "From date of randomization until the date of first documented progression, assessed up to 104 weeks
Progression Free Survival (PFS)
Time from the date of initiation of study therapy to the date measurement criteria are first met for progressive disease or death from any cause, whichever occurs first.
Time frame: "From date of randomization until the date of first documented progression, assessed up to 104 weeks