Status:
ACTIVE_NOT_RECRUITING
A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2025
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04397276
Start Date
July 10 2020
End Date
October 30 2025
Last Update
September 12 2025
Active Locations (7)
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1
BC Cancer Agency - Vancouver BC
Vancouver, British Columbia, Canada, V5Z 4E6
2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
3
Rambam Medical Center
Haifa, Israel, 31096
4
Sourasky Medical Center
Tel Aviv, Israel, 64239