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NCT05620134

Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer

StatusUnknown
PhasePhase 1/2
Primary completion (estimated)
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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Oct 2024); last known: Active, Not Recruiting
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 11 of 11 sites
    v7
  3. Eligibility criteria expanded, about 55 words
    • Interventions: JK08 (Drug), Pembrolizumab (Drug) to JK08 (Drug), Lenvatinib Pill (Drug), Pembrolizumab (Drug)
    • Study arms: 3 to 4
    v6
  4. Study title shortened, about 22 wordsv5
  5. Enrollment target: 149 to 263v4 Show 6 more changesShow less
    • Eligibility criteria shortened, about 305 words
    • Study sites: 4 to 11
    • Interventions: JK08 (Drug) to JK08 (Drug), Pembrolizumab (Drug)
    • Study description shortened, about 13 words
    • Study title expanded, about 14 words
    • Study arms: 5 to 3
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 2 to 4v3
  2. Study sites: 1 to 2v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Dose-limiting Toxicity (DLT)
Timeframe: First 21 days of treatment.
Dose-Finding
Timeframe: Screening to 90 days from last dose.
Safety and Tolerability
Timeframe: First treatment through 28 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.

Secondary (5)

Pharmacokinetics of JK08
Objective Response Rate (ORR)
Disease Control Rate (DCR)
Progression Free Survival (PFS)
Overall Survival (OS)

Arms and interventions

Dose EscalationExperimental

Escalating 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 CancerExperimental

JK08 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 CancerExperimental

JK08 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 CancerExperimental

JK08 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

Drugs: JK08, Pembrolizumab, Lenvatinib Pill

Sites

11 sites in 2 countries

Spain 7, Belgium 4