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).
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
Drug | Synonyms | Arms |
---|
JNJ-69086420 | 225Ac-DOTA-h11B6 | Part 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
Name | Type | Description | Interventions |
---|
Part 1: Dose Escalation | Experimental | 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. | |
Part 2: Dose Expansion | Experimental | Participants will receive intravenous (IV) injection of JNJ-69086420 at one of the RP2D(s) determined in Part 1. | |
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
June 18, 2021