A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer
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 Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| 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 Names:
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| 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:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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
- Percentage of Participants with Prostate Specific Antigen (PSA) Response [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.
- 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).
- 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.
- 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.
- 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.
- 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
Inclusion Criteria:
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Histologic: metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed
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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
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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.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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Adequate organ functions as reflected in laboratory parameters
Exclusion Criteria:
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Part 1: Prior treatment with radium Xofigo (Ra 223 dichloride), strontium, or samarium therapy or radioconjugate therapy
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Known history of myelodysplastic syndrome, leukemia, or hematological malignancy with features suggestive of myelodysplastic syndrome/acute myeloid leukemia at any timepoint
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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)
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Known allergies, hypersensitivity, or intolerance to JNJ-69086420 or its excipients and protein therapeutics
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Active or chronic hepatitis B or hepatitis C infection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope | Duarte | California | United States | 91010 |
| 2 | UCLA Medical Center | Los Angeles | California | United States | 90095 |
| 3 | University of California San Francisco | San Francisco | California | United States | 94158-2549 |
| 4 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 5 | Tulane School Of Medicine | New Orleans | Louisiana | United States | 70112 |
| 6 | Urology Cancer Center and GU Research Network | Omaha | Nebraska | United States | 68130 |
| 7 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 8 | University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112 |
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
Publications
None provided.- CR108817
- 69086420PCR1001