A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers
JNJ-63723283: JNJ-63723283 will be administered by IV infusion or SC injection or infusion.
Study summary
The Primary purpose of this study is to identify the recommended Phase 2 dose \[RP2D(s)\] for JNJ-63723283 in Part 1, to assess the anti-tumor activity of JNJ-63723283 at the RP2D(s) in participants with selected advanced cancers including non-small-cell lung cancer (NSCLC), melanoma, renal, bladder, small-cell lung cancer (SCLC), gastric/esophageal cancer, and high-level microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer (CRC) in Part 2, to determine one or more additional RP2Ds in Parts 3 and 4.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Part 1: Frequency and Severity of Dose-Limiting Toxicity (DLT) — Up to 2 years 6 months Frequency and severity of dose-limiting toxicity will be reported.
Part 2: Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Subjects With Selected Advanced Solid Tumors — Up to 2 years 6 months 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.
Parts 3 and 4: Area Under the Serum Concentration Versus Time Curve from Time Zero to Dosing Interval (AUC [0-tau]) — Up to 2 years 6 months AUC (0-tau) is defined as area under the serum concentration versus time curve from time zero to dosing interval.
Trial sites (20)
Facility
City
Region
Status
—
St Louis
Missouri
—
Pittsburgh
Pennsylvania
—
Chisinau
Moldova
—
Bialystok
Poland
—
Warsaw
Poland
—
Moscow
Russia
—
Pyatigorsk
Russia
—
Saint Petersburg
Russia
—
Badalona
Spain
—
Barcelona
Spain
—
Madrid
Spain
—
Málaga
Spain
—
Pamplona
Spain
—
Seville
Spain
—
Valencia
Spain
—
Gothenburg
Sweden
—
Glasgow
United Kingdom
—
London
United Kingdom
—
Manchester
United Kingdom
—
Newcastle upon Tyne
United Kingdom
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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