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

A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: JNJ-70218902

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 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 preliminary clinical efficacy, 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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BC Cancer Agency - Vancouver BC
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
• Israel
  • Haifa, Israel, 31096
    • Rambam Medical Center
  • Tel Aviv, Israel, 64239
    • Sourasky Medical Center
• Spain
  • Barcelona, Spain, 08035
    • Hosp Univ Vall D Hebron
  • Madrid, Spain, 28040
    • Hosp Univ Fund Jimenez Diaz
  • Madrid, Spain, 28050
    • Hosp Univ Hm Sanchinarro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Dose Escalation; Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-70218902. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.	Drug: JNJ-70218902; JNJ-70218902 will be administered.
Experimental: Part 2: Dose Expansion; Participants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1.	Drug: JNJ-70218902; JNJ-70218902 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 2.5 years
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)	Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.	Up to 21 days
Part 1 and Part 2: Number of Participants with AEs by Severity	Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS), which will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.	Up to 2.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Serum Concentration (Cmax) of JNJ-70218902	Cmax is the maximum observed serum concentration of JNJ-70218902.	Up to 2.5 years
Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-70218902	Tmax is defined as time to reach maximum observed serum concentration.	Up to 2.5 years
Area Under the Serum Concentration-time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-70218902	AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2.	Up to 2.5 years
Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-70218902	AUCtau is the measure of the serum drug concentration from time zero to end of dosing interval.	Up to 2.5 years
Minimum Observed Serum Concentration (Cmin) of JNJ-70218902	Cmin is the minimum observed serum concentration of JNJ-70218902.	Up to 2.5 years
Accumulation Ratio (RA) of JNJ-70218902	Accumulation Ratio (RA) is calculated as area under the plasma concentration-time curve from time zero to 24 hours (AUC [0-24]) value at steady state divided by AUC (0-24) value after first dose.	Up to 2.5 years
Systemic Cytokine Concentrations	Cytokines concentration will be measured for biomarker assessment.	Up to 2.5 years
Serum Prostate Specific Antigen (PSA) Concentration	Serum prostate specific antigen (PSA) concentration will be measured.	Up to 2.5 years
Number of Participants With Anti-JNJ-70218902 Antibodies	Number of participants with anti-JNJ-70218902 antibodies will be assessed.	Up to 2.5 years
Objective Response Rate (ORR)	ORR is defined as the percentage of participants who have a Partial Response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3).	Up to 2.5 years
Duration of Response (DOR)	Duration of response (DOR) will be calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first.	Up to 2.5 years

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): September 16, 2025
• Study Completion (Actual): September 16, 2025

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Prostate Cancer; metastatic Castration-Resistant Prostate Cancer (mCRPC)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Neoplasms; Prostatic Neoplasms
• Other Study ID Numbers: CR108765; 2019-004885-16 (EudraCT Number); 70218902EDI1001 (Other Identifier: Janssen Research & Development, LLC); 2024-516351-40-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes