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

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ClinicalTrials.gov Identifier: NCT04644770
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE November 20, 2020
First Posted Date  ICMJE November 25, 2020
Last Update Posted Date March 29, 2021
Actual Study Start Date  ICMJE November 12, 2020
Estimated Primary Completion Date March 23, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
  • Percentage of Participants with Prostate Specific Antigen (PSA) Response [ Time Frame: Week 12 ]
    PSA response rate is defined as the percentage of participants with a decline of PSA of 50 percent (%) or more from baseline at Week 12.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer
Official Title  ICMJE A Phase 1 Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostatic Neoplasms
  • Adenocarcinoma
Intervention  ICMJE Drug: JNJ-69086420
Participants will receive IV injection of JNJ-69086420.
Other Name: 225Ac-DOTA-h11B6
Study Arms  ICMJE
  • 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.
    Intervention: Drug: JNJ-69086420
  • Experimental: Part 2: Dose Expansion
    Participants will receive intravenous (IV) injection of JNJ-69086420 at one of the RP2D(s) determined in Part 1.
    Intervention: Drug: JNJ-69086420
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 20, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 7, 2023
Estimated Primary Completion Date March 23, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04644770
Other Study ID Numbers  ICMJE CR108817
69086420PCR1001 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP