A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancers

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506144-16-00

Acronym

63723283LUC1001

Enrollment

Registered

2024-07-16

Start date

2016-12-06

Completion date

Unknown

Last updated

2025-03-16

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

Conditions

Advanced Stage Solid Tumors

Brief summary

Frequency and severity of DLT (Part 1); Overall response rate per the RECIST version 1.1 in subjects with selected advanced solid tumors (Part 2); JNJ-63723283 PK parameters after 1st dose administration as observed in Part 3 and JNJ-63723283 PK parameters after 4th dose as observed during Q3W dosing in Part 4

Interventions

DRUGcetrelimab

DRUGJNJ-63723283

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Frequency and severity of DLT (Part 1); Overall response rate per the RECIST version 1.1 in subjects with selected advanced solid tumors (Part 2); JNJ-63723283 PK parameters after 1st dose administration as observed in Part 3 and JNJ-63723283 PK parameters after 4th dose as observed during Q3W dosing in Part 4	—

Countries

Poland, Spain

Outcome results

None listed

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