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A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04644770
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief Summary:
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of JNJ-69086420 in Part 1 (Dose Escalation) and to determine safety and and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion).

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Adenocarcinoma Drug: JNJ-69086420 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : March 19, 2025
Estimated Study Completion Date : July 16, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Dose Escalation
Participants will receive intravenous (IV) injection of JNJ-69086420 with one or multiple doses. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.
 Drug: JNJ-69086420
Participants will receive IV injection of JNJ-69086420.
Other Name: 225Ac-DOTA-h11B6
Experimental: Part 2: Dose Expansion
Participants will receive intravenous (IV) injection of JNJ-69086420 at one of the RP2D(s) determined in Part 1.
 Drug: JNJ-69086420
Participants will receive IV injection of JNJ-69086420.
Other Name: 225Ac-DOTA-h11B6


Outcome Measures
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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 years and 4 months ]
    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 2 years and 4 months ]
    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 years and 4 months ]
    Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. 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. Percentage of Participants with Prostate Specific Antigen (PSA) Response [ Time Frame: Up to 2 years and 4 months ]
    PSA response rate is defined as the percentage of participants with a decline of PSA of 50 percent (%) or more from baseline and that is subsequently confirmed.

  2. Overall Response Rate (ORR) [ Time Frame: Up to 2 years and 4 months ]
    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).

  3. Maximum Observed Serum Concentration/Radioactivity (Cmax) of JNJ-69086420 [ Time Frame: Up to 2 years and 4 months ]
    Cmax is defined as the maximum observed serum concentration/radioactivity of JNJ-69086420.

  4. Time to Reach Maximum Observed Serum Concentration/Radioactivity (Tmax) of JNJ-69086420 [ Time Frame: Up to 2 years and 4 months ]
    Tmax is defined as time to reach maximum observed serum concentration/radioactivity of JNJ-69086420.

  5. Area Under the Serum Concentration-time Curve From Time Zero to t Time (AUC[0-t]) of JNJ-69086420 [ Time Frame: Up to 2 years and 4 months ]
    AUC(0-t) is defined as the area under the serum concentration-time curve from time zero to t of JNJ-69086420.

  6. Number of Participants With Anti-JNJ-69086420 Antibodies [ Time Frame: Up to 2 years and 4 months ]
    Number of participants with anti-JNJ-69086420 antibodies will be assessed to evaluate the potential immunogenicity.


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • Histologic: metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed
  • Must have had prior exposure to at least one novel androgen receptor (AR) targeted therapy (example, abiraterone acetate, enzalutamide, apalutamide, darolutamide); prior taxane or other chemotherapy is acceptable but not required
  • Treatment with other agents for prostate cancer, if received, must have been discontinued greater than or equal to (>=) 2 weeks prior to first dose of study drug.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ functions as reflected in laboratory parameters

Exclusion Criteria:

  • Part 1: Prior treatment with radium Xofigo (Ra 223 dichloride), strontium, or samarium therapy or radioconjugate therapy
  • Known history of myelodysplastic syndrome, leukemia, or hematological malignancy with features suggestive of myelodysplastic syndrome/acute myeloid leukemia at any timepoint
  • Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade less than or equal to <= 1 (except alopecia, radiation tissue fibrosis, or peripheral neuropathy)
  • Known allergies, hypersensitivity, or intolerance to JNJ-69086420 or its excipients and protein therapeutics
  • Active or chronic hepatitis B or hepatitis C infection.
Contacts and Locations
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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): NCT04644770


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Louisiana
Tulane School Of Medicine Recruiting
New Orleans, Louisiana, United States, 70112
United States, Nebraska
XCancer Omaha / Urology Cancer Center Recruiting
Omaha, Nebraska, United States, 68130
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Utah
University of Utah Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04644770    
Other Study ID Numbers: CR108817
69086420PCR1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
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/clinicaltrials/ 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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases