Study on the Safety and Effects of JNJ-63723283, an Anti-PD-1 Antibody, in People with Advanced Cancers

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT02908906

This clinical trial is testing a new drug, JNJ-63723283, to find the best dose and see how well it works against various advanced cancers, including lung, melanoma, kidney, bladder, stomach, and certain types of colorectal cancer.

Patient Parameters

Program Overview

The main goal of this study is to determine the safest and most effective dose of JNJ-63723283, an anti-PD-1 antibody, for treating advanced cancers. The study will also evaluate how well the drug works in shrinking tumors in patients with specific types of advanced cancers, such as non-small-cell lung cancer, melanoma, kidney, bladder, small-cell lung cancer, gastric/esophageal cancer, and certain colorectal cancers with specific genetic features.

Eligibility Criteria

Inclusion Criteria

  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Thyroid function must be within normal limits.
  • Women who can have children must have a negative pregnancy test.
  • Must be willing to follow the study's rules and restrictions.
  • For Part 2: Must have tumor tissue available for study purposes, with a preference for a fresh biopsy. If using stored tissue, it must meet specific storage criteria.
  • Must have a disease that can be evaluated by the study team.

Exclusion Criteria

  • Have any uncontrolled illness, such as active infections needing IV antibiotics, severe heart failure, unstable chest pain, irregular heartbeats, poorly managed high blood pressure or diabetes, or mental health issues that would interfere with the study.
  • Have previously been treated with anti-PD-1, PD-L1, or PD-L2 antibodies.
  • Have received any cancer treatment, including local or systemic therapy, radiation (except limited palliative radiation), or experimental drugs within 14 days or 4 half-lives (up to 28 days) before starting the study drug.
  • Have experienced severe side effects (Grade 3 or higher) from previous immunotherapy.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study or within 5 months after the last dose of the study drug.

Locations

FACILITYZIPCITYSTATE
St LouisMissouri
PittsburghPennsylvania

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