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

NCT04397276 | Completed Phase 1 FDA Drug

• 4 other identifiers: CR10876570218902EDI10012019-004885-162024-516351-40-00
• Study Type: interventional
• Target: 82
• Locations: 3 countries
• Sites: 7

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 Part 2.

Conditions

Neoplasms

Keywords

metastatic Castration-Resistant Prostate Cancer (mCRPC); Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Maximum Observed Serum Concentration (Cmax) of JNJ-70218902

  Up to 2.5 years

• Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-70218902

  Up to 2.5 years

• Area Under the Serum Concentration-time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-70218902

  Up to 2.5 years

• Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-70218902

  Up to 2.5 years

• Minimum Observed Serum Concentration (Cmin) of JNJ-70218902

  Up to 2.5 years

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

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

Part 2: Dose Expansion

EXPERIMENTAL

Participants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1.

Drug: JNJ-70218902

Interventions

JNJ-70218902 DRUG

JNJ-70218902 will be administered.

Part 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (7)

BC Cancer Agency - Vancouver BC

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

Location

Hosp Univ Hm Sanchinarro

Madrid, 28050, Spain

Location

MeSH Terms

Conditions

Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: July 10, 2020
• Primary Completion: September 16, 2025
• Study Completion: September 16, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (2); IL (2); ES (3)