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

Prostatic Neoplasms Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04644770
• Other study ID #: CR108817
• Secondary ID: 69086420PCR1001
• Status: Recruiting
• Phase: Phase 1
• Start date: November 12, 2020
• Est. completion date: December 26, 2025

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: December 26, 2025
• Est. primary completion date: December 26, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Metastatic castration resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma (adenocarcinoma with small-cell or neuroendocrine features is allowed) with prior exposure to at least one androgen receptor (AR) targeted therapy (example, abiraterone acetate, enzalutamide, apalutamide, darolutamide). In addition: Part 1: prior taxane or other chemotherapy is acceptable but not required. Part 2a: prior taxane or other chemotherapy required, Part 2b: no prior taxane or other chemotherapy, Part 2c: mCRPC that has progressed after prior treatment with lutetium Lu-177 vipivotide tetraxetan
• Prior orchiectomy or medical castration; or, for participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist) prior to the first dose of study drug and must continue this therapy throughout the treatment phase
• Palliative radiotherapy (for example [eg], soft tissue lesions) must be completed greater than (>) 2 weeks prior to start of study drug except for palliative radiotherapy for pain (eg, bone pain), which may be used any time prior to first dose
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ functions as reflected in laboratory parameters

Exclusion Criteria:

• Prior treatment with radium Xofigo (Ra 223 dichloride), strontium, samarium, or other radioconjugate therapy. In addition: Part 2b: Prior treatment with chemotherapy (eg, docetaxel) or poly ADP ribose polymerase (PARP) inhibitors. Part 2c: Prior treatment with lutetium Lu-177 vipivotide tetraxetan is permitted
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostatic Neoplasms

Intervention

Drug:
• JNJ-69086420
Participants will receive IV injection of JNJ-69086420.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	City of Hope	Duarte	California
United States	Tulane School Of Medicine	New Orleans	Louisiana
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	XCancer Omaha / Urology Cancer Center	Omaha	Nebraska
United States	University of Utah Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	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.	Up to 2 years and 4 months
Primary	Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)	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.	Up to 2 years and 4 months
Primary	Part 1 and Part 2: Number of Participants with AEs by Severity	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.	Up to 2 years and 4 months
Secondary	Percentage of Participants with Prostate Specific Antigen (PSA) Response	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.	Up to 2 years and 4 months
Secondary	Overall Response Rate (ORR)	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).	Up to 2 years and 4 months
Secondary	Maximum Observed Serum Concentration/Radioactivity (Cmax) of JNJ-69086420	Cmax is defined as the maximum observed serum concentration/radioactivity of JNJ-69086420.	Up to 2 years and 4 months
Secondary	Time to Reach Maximum Observed Serum Concentration/Radioactivity (Tmax) of JNJ-69086420	Tmax is defined as time to reach maximum observed serum concentration/radioactivity of JNJ-69086420.	Up to 2 years and 4 months
Secondary	Area Under the Serum Concentration-time Curve From Time Zero to t Time (AUC[0-t]) of JNJ-69086420	AUC(0-t) is defined as the area under the serum concentration-time curve from time zero to t of JNJ-69086420.	Up to 2 years and 4 months
Secondary	Number of Participants With Anti-JNJ-69086420 Antibodies	Number of participants with anti-JNJ-69086420 antibodies will be assessed to evaluate the potential immunogenicity.	Up to 2 years and 4 months