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
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT02908906
This study evaluates JNJ-63723283, an anti-PD-1 monoclonal antibody, for safety and efficacy in advanced cancers. Participants must have an ECOG status of 0 or 1, normal thyroid function, and evaluable disease. Females must test negative for pregnancy. JNJ-63723283 is administered via IV or SC. Part 2 requires tumor tissue for correlative studies.
Patient Parameters
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Program Overview
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 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| St Louis | Missouri | ||
| Pittsburgh | Pennsylvania |
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