A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors

  • STATUS
    Recruiting
  • participants needed
    70
  • sponsor
    Janssen Research & Development, LLC
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Updated on 16 February 2024
See if I qualify
adenocarcinoma
targeted therapy
gnrh
gonadotropin releasing hormone
solid neoplasm
castration-resistant prostate cancer
prostate cancer

Summary

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.

Details
Condition Cancer
Age 18years - 100years
Treatment JNJ-70218902
Clinical Study IdentifierNCT04397276
SponsorJanssen Research & Development, LLC
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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adenocarcinoma
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