Overview
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) and maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of JNJ-70218902 RP2D(s) in Part 2.
Description
JNJ-70218902, the investigational drug, has been shown in pre-clinical studies to work by attaching to cancer cells and activating immune cells to kill these cancer cells.This study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2) and will enroll adult men with Metastatic Castration-Resistant Prostate Cancer (MCRPC). Study evaluations will include safety, pharmacokinetics, biomarkers and immunogenicity evaluations. This study is divided into 3 periods: screening, treatment and post-treatment. The total duration of the study will be 2.5 years approximately.
Eligibility
Inclusion Criteria:
- Histology: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed
- Measurable or evaluable disease
- Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy
- If the participant is receiving treatment with gonadotropin-releasing hormone agonists or antagonist analogs (GnRH), this therapy must have been initiated prior to first dose of study drug and must be continued throughout the study
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- Adequate organs functions
- Archived tissue at baseline are requested
- Participants with accessible lesions enrolled in selected cohorts in Part 1 and 2 will undergo fresh tumor biopsies
Exclusion Criteria:
- Known brain metastases
- Concurrent use of any other anticancer treatment or investigational agent for the treatment of advanced disease
- Toxicities related to prior anticancer treatments have not returned to Grade less than or equal to (<=) 1 or baseline, except for alopecia and vitiligo
- Solid organ or bone marrow transplantation
- Known allergies, hypersensitivity, or intolerance to JNJ-70218902 or its excipients
- Certain comorbidities