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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511750-53-00

Acronym

JK08.1.01

Enrollment

130

Registered

2024-05-06

Start date

2022-09-08

Completion date

2025-04-25

Last updated

2025-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable Locally Advanced or Metastatic Cancer

Brief summary

MTD and/or DLT after one cycle of treatment and all SAEs, AEs tabulated/reported by type, grade, and frequency for the entire study duration.

Detailed description

PK (analysis of Cmax, AUC, tmax, and t½ following treatment completion)., ADA status., ORR according to standard RECIST 1.1 criteria., DCR and PFS by RECIST 1.1 and OS in patients with advanced solid tumors.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGLENVIMA 4 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
MTD and/or DLT after one cycle of treatment and all SAEs, AEs tabulated/reported by type, grade, and frequency for the entire study duration.	—

Secondary

Measure	Time frame
PK (analysis of Cmax, AUC, tmax, and t½ following treatment completion)., ADA status., ORR according to standard RECIST 1.1 criteria., DCR and PFS by RECIST 1.1 and OS in patients with advanced solid tumors.	—

Countries

Belgium, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026