A Study to Evaluate the Safety, Pharmacokinetics, Pharmac... | NCT02908906

ID	Type	Description
63723283LUC1001	Other Identifier	Janssen Research & Development, LLC
2016-002017-22	EudraCT Number
2023-506144-16-00	Registry Identifier	EUCT number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JNJ-63723283	Experimental	In Part 1, the first cohort will receive JNJ-63723283 at a starting dose of 80 milligram (mg), intravenous (IV) every 2 weeks. JNJ-63723283 doses will be escalated following a modified Continual Reassessment Method (mCRM). Multiple doses, dose administration routes (subcutaneous [SC] or IV), and dose schedules may be explored. In Part 2, participants will receive JNJ-63723283 at the recommended Phase 2 dose (RP2D) determined in Part 1. In Part 3, participants will receive JNJ-63723283 to evaluate pharmacokinetic (PK), pharmacodynamic (PD) and safety. In Part 4, participants will receive JNJ-63723283 at the dose level determined in Part 3. Additional cohorts may be enrolled in Part 4.	Drug: JNJ-63723283

Name	Type	Description	Arm Group Labels	Other Names
JNJ-63723283	Drug	JNJ-63723283 will be administered by IV infusion or SC injection or infusion.	JNJ-63723283

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1: Frequency and Severity of Dose-Limiting Toxicity (DLT)	Frequency and severity of dose-limiting toxicity will be reported.	Up to 2 years 6 months
Part 2: Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Subjects With Selected Advanced Solid Tumors	Objective Response Rate (ORR) is defined as percentage of subjects with best objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.	Up to 2 years 6 months
Parts 3 and 4: Area Under the Serum Concentration Versus Time Curve from Time Zero to Dosing Interval (AUC [0-tau])	AUC (0-tau) is defined as area under the serum concentration versus time curve from time zero to dosing interval.	Up to 2 years 6 months

Secondary Outcomes

Measure	Description	Time Frame
Parts 1, 2, 3, and 4 : Number of Participants With Adverse Events (AEs) as a Measure of Safety	An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.	Up to 2 years 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parts 1-4: Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1
Parts 1-4: Has thyroid function laboratory values within normal range
Parts 1-4: Females of childbearing potential must have a negative serum pregnancy test
Parts 1-4: Willing and able to adhere to the prohibitions and restrictions specified in this protocol
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
Parts 1 to 4: Have evaluable disease

Exclusion Criteria:

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
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
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
Grade 3 or higher toxicity effects from previous treatment with immunotherapy
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

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42313189	Derived	Rutkowski P, Kowalski DM, Moreno V, Calvo A, Thistlethwaite F, Plummer R, Steinbach D, Loffredo J, Akapeme S, Jonathan D, Philip V, Girvin A, Hampras S, Hellemans P, Bulat I. A phase I study evaluating subcutaneous administration of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced solid malignancies. Cancer Immunol Immunother. 2026 Jun 18. doi: 10.1007/s00262-026-04457-1. Online ahead of print.
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Facility	Status	City	State	ZIP	Country	Contacts
		St Louis	Missouri		United States