Clinical Trials /

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

NCT04644770

Description:

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).

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer
  • Official Title: A Phase 1 Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: CR108817
  • SECONDARY ID: 69086420PCR1001
  • NCT ID: NCT04644770

Conditions

  • Prostatic Neoplasms
  • Adenocarcinoma

Interventions

DrugSynonymsArms
JNJ-69086420225Ac-DOTA-h11B6Part 1: Dose Escalation

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Part 1: Dose EscalationExperimentalParticipants 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.
  • JNJ-69086420
Part 2: Dose ExpansionExperimentalParticipants will receive intravenous (IV) injection of JNJ-69086420 at one of the RP2D(s) determined in Part 1.
  • JNJ-69086420

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Percentage of Participants with Prostate Specific Antigen (PSA) Response
Time Frame:Week 12
Safety Issue:
Description: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.
Measure:Overall Response Rate (ORR)
Time Frame:Up to 2 years and 4 months
Safety Issue:
Description: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).
Measure:Maximum Observed Serum Concentration/Radioactivity (Cmax) of JNJ-69086420
Time Frame:Up to 2 years and 4 months
Safety Issue:
Description:Cmax is defined as the maximum observed serum concentration/radioactivity of JNJ-69086420.
Measure:Time to Reach Maximum Observed Serum Concentration/Radioactivity (Tmax) of JNJ-69086420
Time Frame:Up to 2 years and 4 months
Safety Issue:
Description:Tmax is defined as time to reach maximum observed serum concentration/radioactivity of JNJ-69086420.
Measure: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
Safety Issue:
Description:AUC(0-t) is defined as the area under the serum concentration-time curve from time zero to t of JNJ-69086420.
Measure:Number of Participants With Anti-JNJ-69086420 Antibodies
Time Frame:Up to 2 years and 4 months
Safety Issue:
Description:Number of participants with anti-JNJ-69086420 antibodies will be assessed to evaluate the potential immunogenicity.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Janssen Research & Development, LLC

Last Updated

November 25, 2020