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

Phase 1

Recruiting

• Conditions: Prostatic Neoplasms; Adenocarcinoma
• Interventions: Drug: JNJ-69086420

• Registration Number: NCT04644770
• Lead Sponsor: Janssen Research & Development, LLC

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-12
• Study First Submitted: 2020-11-20
• Study First Submitted QC: 2020-11-20
• Study First Posted: 2020-11-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-06
• Primary Completion: 2027-09-07
• Study Completion: 2028-08-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 231

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1: Dose Escalation	JNJ-69086420	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	JNJ-69086420	Participants in one or more cohorts will receive intravenous (IV) injection of JNJ-69086420 at the RP2D(s) determined in Part 1.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (7)

XCancer Omaha / Urology Cancer Center; 🇺🇸 Omaha, Nebraska, United States

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Tulane School Of Medicine; 🇺🇸 New Orleans, Louisiana, United States

University of Utah Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

City of Hope; 🇺🇸 Duarte, California, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States