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Completed

NCT Number: NCT04397276

A Study of JNJ-70218902 in Participants With 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

BC Cancer Agency - Vancouver BC, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-70218902

Drug

JNJ-70218902 will be administered.

Primary outcomes

  1. Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

    Time frame: Up to 2.5 years

    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.

  2. Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)

    Time frame: Up to 21 days

    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.

  3. Part 1 and Part 2: Number of Participants with AEs by Severity

    Time frame: Up to 2.5 years

    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.

Secondary outcomes

  1. Maximum Observed Serum Concentration (Cmax) of JNJ-70218902

    Time frame: Up to 2.5 years

    Cmax is the maximum observed serum concentration of JNJ-70218902.

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

    Time frame: Up to 2.5 years

    Tmax is defined as time to reach maximum observed serum concentration.

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

    Time frame: Up to 2.5 years

    AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2.

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

    Time frame: Up to 2.5 years

    AUCtau is the measure of the serum drug concentration from time zero to end of dosing interval.

  5. Minimum Observed Serum Concentration (Cmin) of JNJ-70218902

    Time frame: Up to 2.5 years

    Cmin is the minimum observed serum concentration of JNJ-70218902.

  6. Accumulation Ratio (RA) of JNJ-70218902

    Time frame: Up to 2.5 years

    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.

  7. Systemic Cytokine Concentrations

    Time frame: Up to 2.5 years

    Cytokines concentration will be measured for biomarker assessment.

  8. Serum Prostate Specific Antigen (PSA) Concentration

    Time frame: Up to 2.5 years

    Serum prostate specific antigen (PSA) concentration will be measured.

  9. Number of Participants With Anti-JNJ-70218902 Antibodies

    Time frame: Up to 2.5 years

    Number of participants with anti-JNJ-70218902 antibodies will be assessed.

  10. Objective Response Rate (ORR)

    Time frame: Up to 2.5 years

    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).

  11. Duration of Response (DOR)

    Time frame: Up to 2.5 years

    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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 21, 2020
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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