Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer (NCT05620134) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer
Belgium, Spain263 participantsStarted 2022-10-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. Expansion Combination Cohorts
. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
. Life expectancy ≥ 12 weeks.
. Measurable disease as per RECIST 1.1 criteria and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose-limiting Toxicity (DLT)
Timeframe: First 21 days of treatment.
2
Dose-Finding
Timeframe: Screening to 90 days from last dose.
3
Safety and Tolerability
Timeframe: First treatment through 28 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
4
Safety and Tolerability
Timeframe: Screening date through 30 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
5
Safety and Tolerability
Timeframe: Screening date through 30 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
. 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:
. History of Grade 3 or greater drug-related immune-mediated AE during treatment with CPIs such as anti-PD-(L)1 or anti-CTLA-4 antibodies.
. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed. At least 2 doses of COVID-19 vaccination must have been completed prior to enrollment (see Section 8.2 for further details).