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Trial record 1 of 1 for:    70218902EDI1001
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A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors

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ClinicalTrials.gov Identifier: NCT04397276
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : December 30, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: JNJ-70218902 Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors
Actual Study Start Date : July 10, 2020
Estimated Primary Completion Date : November 28, 2022
Estimated Study Completion Date : November 28, 2022

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397276


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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United States, California
Cedars Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
United States, Pennsylvania
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Canada, British Columbia
BC Cancer Agency - Vancouver BC Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Israel
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Spain
Hosp. Univ. Vall D'Hebron Recruiting
Barcelona, Spain, 08035
Hosp. Univ. Fund. Jimenez Diaz Recruiting
Madrid, Spain, 28040
Hosp. Univ. Hm Sanchinarro Recruiting
Madrid, Spain, 28050
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04397276    
Other Study ID Numbers: CR108765
2019-004885-16 ( EudraCT Number )
70218902EDI1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: December 30, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
URL: https://www.janssen.com/clinical-trials/transparency

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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
Keywords provided by Janssen Research & Development, LLC:
metastatic Castration-Resistant Prostate Cancer (mCRPC)
Prostate Cancer