A Phase 1b Study of JNJ-78278343 a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2) in Combination with either JNJ-63723283 (cetrelimab) Taxane Chemotherapy or Androgen Receptor Pathway Inhibitors for Metastatic Castration- Resistant Prostate Cancer

Brief description of study

This study will test the early effects of the immunotherapy drug JNJ-78278343, a bispecific antibody targeting KLK2 and CD3, combined with taxane chemotherapy or androgen receptor pathway inhibitor in adults with metastatic castration-resistant prostate cancer (mCRPC) who have already had at least one treatment. The study has two parts: Part 1, which will find the most effective dose by testing different amounts of the drugs in patients and Part 2 will include patients for each dose found to have few or no side effects and effective. A team of experts will watch for any safety issues and can stop the study if needed. The study has a Screening Period before treatment begins, a Treatment Period while the drugs are given, and an End of Treatment (EOT) visit when the treatment stops. Patients will be checked for side effects for up to 100 days after their last dose of cetrelimab or 30 days after their last dose of JNJ-78278343, depending on which comes later.


Clinical Study Identifier: s24-00716
ClinicalTrials.gov Identifier: NCT05818683
Principal Investigator: David R. Wise.
Other Investigators: Maya Dimitrova, Victor Ricardo Adorno Febles, Minas Platon Economides, Scot Niglio, Mary K O'Keeffe, Hank Ng.


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