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

Who is this study for? Adult male patients with Prostate Cancer
What treatments are being studied? JNJ-69086420 Anti-Kallikrein-2 Actinium-225-Labeled Antibody
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1
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), to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion), to determine safety of JNJ-69086420 at the RP2D(s) as a combination therapy in Part 3 (combination therapy) and to determine safety of JNJ-69086420 at the RP2D(s) in participants with metastatic hormone-sensitive prostate cancer (mHSPC) in Part 4.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• For Part 1, Part 2, Part 3: 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 (for example \[e.g.\], 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, with or without prior chemotherapy, Part 3: prior taxane or other chemotherapy is acceptable but not required \& For Part 4a: metastatic HSPC, For Part 4b: disease that can be treated with less than or equal to (\<=) 5 radiation fields and no visceral metastases

• Parts 1, 2 \& 3: 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. This criterion does not apply to Part 4

• Palliative radiotherapy (e.g. soft tissue lesions) must be completed greater than (\>) 2 weeks prior to start of study drug except for palliative radiotherapy for pain (e.g., 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

Locations
United States
California
City of Hope
RECRUITING
Duarte
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Illinois
University of Chicago
RECRUITING
Chicago
Louisiana
East Jefferson General Hospital
RECRUITING
Metairie
Tulane University Hospital & Clinics
RECRUITING
New Orleans
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Nebraska
XCancer Omaha / Urology Cancer Center
RECRUITING
Omaha
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
Case Western Reserve University
RECRUITING
Cleveland
Utah
University of Utah Huntsman Cancer Institute
RECRUITING
Salt Lake City
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2020-11-12
Estimated Completion Date: 2028-11-28
Participants
Target number of participants: 247
Treatments
Experimental: Part 1: Dose Escalation
Participants will receive 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.
Experimental: Part 2: Dose Expansion
Participants in one or more cohorts will receive JNJ-69086420 at the RP2D(s) determined in Part 1.
Experimental: Part 3: Combination Therapy
Participants will receive JNJ-69086420 at the determined RP2D(s) and fixed dose of JNJ-78278343.
Experimental: Part 4: HSPC Expansion
Participants with HSPC will receive JNJ-69086420 at the RP2D(s) in Part 4(a), and JNJ-69086420 following stereotactic body radiation therapy in Part 4(b).
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov