CETRELIMAB for Advanced solid tumors

Inclusion criteria

• {"criterion_text":"- 1. Parts 1-4: Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1"}
• {"criterion_text":"- 2. Parts 1-4: Has thyroid function laboratory values within normal range"}
• {"criterion_text":"- 3. Parts 1-4: Females of childbearing potential must have a negative serum pregnancy test"}
• {"criterion_text":"- 4.Parts 1-4: Willing and able to adhere to the prohibitions and restrictions specified in this protocol"}
• {"criterion_text":"- 5. Participant must have evaluable disease. For Part 2 only: Participants enrolled into Part 2 must have tumor tissue available for correlative studies. Fresh tumor biopsy is preferred. Archival tissue must meet the following criteria: archival sections within 4 months of sectioning that have been stored at 2 degree to 8 degree Celsius in the dark or archival tumor blocks within 5 years of collection. Participants without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy"}
• {"criterion_text":"- 6. Parts 1 to 4: Have evaluable disease"}

Exclusion criteria

• {"criterion_text":"- 1. Has uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure (New York Heart Association class III-IV), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that would limited compliance with study requirements"}
• {"criterion_text":"- 2. Has had prior treatment with an anti-Programmed-cell death receptor-1 (PD-1) antibody, anti-the ligand to programmed-cell death 1 (PD-L1) antibody or anti-the ligand to programmed-cell death 2 (PD-L2) antibody"}
• {"criterion_text":"- 3. Treatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 half lives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administration"}
• {"criterion_text":"- 4. Grade 3 or higher toxicity effects from previous treatment with immunotherapy"}
• {"criterion_text":"- 5. A female who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 5 months after the last dose of study drug"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"DLT frequency/severity assessed (Part 1); Overall response rate measured per RECIST v1.1 (Part 2); PK parameters of JNJ-63723283 measured after specified dosing timepoints (Part 3: after 1st dose; Part 4: after 4th dose during Q3W dosing)."}

Spain

Latest Decision Or Authorization Date

11-03-2025

Number Of Sites

2

Number Of Participants

2

Poland

Latest Decision Or Authorization Date

16-02-2026

Number Of Sites

1

Number Of Participants

1

Primary sponsor

Full Name

Janssen - Cilag International

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Third parties

• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Specimen management and storage","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Specimen management and storage","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}