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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04644770
Collaborator
(none)
50
Enrollment
7
Locations
2
Arms
31.8
Anticipated Duration (Months)
7.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 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 :
Nov 12, 2020
Anticipated Primary Completion Date :
Mar 23, 2023
Anticipated Study Completion Date :
Jul 7, 2023

Arms and Interventions

ArmIntervention/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 Names:
  • 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 Names:
  • 225Ac-DOTA-h11B6
  • Outcome Measures

    Primary Outcome Measures

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

    2. Overall Response Rate (ORR) [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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Locations

    SiteCityStateCountryPostal Code
    1City of HopeDuarteCaliforniaUnited States91010
    2UCLA Medical CenterLos AngelesCaliforniaUnited States90095
    3University of California San FranciscoSan FranciscoCaliforniaUnited States94158-2549
    4University of ChicagoChicagoIllinoisUnited States60637
    5Tulane School Of MedicineNew OrleansLouisianaUnited States70112
    6Urology Cancer Center and GU Research NetworkOmahaNebraskaUnited States68130
    7Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10065

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04644770
    Other Study ID Numbers:
    • CR108817
    • 69086420PCR1001
    First Posted:
    Nov 25, 2020
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 3, 2021