Prostate-specific membrane antigen (PSMA) on a prostate sample.
Image Credit: Gerald Chu, M.D., Ph.D.
People with prostate or kidney cancer that has not responded to standard treatments may be eligible to participate in a clinical trial at the NIH Clinical Center.
James L. Gulley, M.D., Ph.D., Chief of the Genitourinary Malignancies Branch, is leading the National Cancer Institute’s participation in a clinical trial of an experimental drug called JNJ-63898081. The goal of this multicenter study is to find out if JNJ-63898081 is safe to use in humans and to determine the optimal dose of JNJ-63898081 for the second phase of the study.
The first part of this study focuses on patients with prostate cancer. Prostate tumors are generally not very “inflamed” with T cells which are the main tumor-fighting weapons of the immune system. JNJ-63898081 is a bispecific antibody that acts as a bridge between T cells and prostate cancer cells that express a protein called PSMA. JNJ-63898081 binds to CD3 on T-cells and PSMA on prostate cancer cells, then activates T cells and redirects them to attack the PSMA-expressing tumor cells. This method of killing tumor cells is unique, giving another option to patients whose disease has not responded to current treatments.
The second part of this study will be open to patients with renal cell carcinoma (kidney cancer). Study participants will be closely monitored for adverse events that could affect their treatment or further participation in the study.
The main goal of the study is to determine how high a dose of JNJ-63898081 can be safe and effective in humans.
Clinicaltrials.gov identifier: NCT03926013
NCI Protocol ID: NCI-20-C-0015
Official Title: A Phase 1, First-in-Human, Dose Escalation Study of JNJ-63898081, in Subjects With Advanced Stage Solid Tumors
The Center for Cancer Research is NCI’s internal cancer center, a publicly funded organization working to improve the lives of cancer patients by solving important, challenging and neglected problems in cancer research and patient care. Highly trained physician-scientists develop and carry out clinical trials to create the medicines of tomorrow treating patients at the world’s largest dedicated research hospital on the campus of the National Institutes of Health in Bethesda, Maryland.
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