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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/3/2019
Start Date:November 2016
End Date:December 2019
Contact:Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email:JNJ.CT@sylogent.com

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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

The Primary purpose of this study is to identify the recommended Phase 2 dose [RP2D(s)] for
JNJ-63723283 in Part 1 and 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.

This is a First in Human (FIH), open-label (all people involved know the identity of the
intervention), multicenter (more than 1 study site) study in participants with advanced
cancers to establish the recommended Phase 2 dose (RP2D[s]) for JNJ-63723283 in Part 1 and to
evaluate the safety and efficacy of the RP2D(s) in Part 2. Subject participation will include
a Screening Phase (28 Days) during which participant eligibility will be reviewed prior to
administration of the first dose of JNJ-63723283; a Treatment Phase that will start at the
first dose and continue until treatment is discontinued; and a Survival Follow-up Phase
starting upon completion of the End-of-Treatment Visit and ends when the participant
completes or withdraws from the study. The end of the study is defined as last study
assessment for the last participant on study or if the sponsor terminates the study,
whichever comes first. Participants safety will be monitored throughout the study.

Inclusion Criteria:

- Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1

- Has thyroid function laboratory values within normal range

- Women of childbearing potential must have a negative serum pregnancy test

- Willing and able to adhere to the prohibitions and restrictions specified in this
protocol

- 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

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
halflives, 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 woman 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
We found this trial at
3
sites
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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71 Via Conca
Ancona, 60126
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Ancona,
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Pittsburgh, Pennsylvania 15232
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Pittsburgh, PA
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