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 range18 Years
SexALL
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).
✓. Acceptable laboratory parameters:
Exclusion criteria
✕. 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:
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.
✕. 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).