Prostatic Neoplasms

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.

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

Castration-Resistant Prostatic Cancer

Prostatic Neoplasms, Castration-Resistant

Genitourinary Cancer

Advanced Solid Tumors

Prostate Neoplasms

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

JNJ-78278343

JNJ-69086420

Stereotactic body radiation therapy

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

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.

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.

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.

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.

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).

Cmax is defined as the maximum observed serum concentration/radioactivity of JNJ-69086420.

Tmax is defined as time to reach maximum observed serum concentration/radioactivity 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.

Number of participants with anti-JNJ-69086420 antibodies will be assessed to evaluate the potential immunogenicity.

Venous blood samples will be collected for assessment of serum concentrations of JNJ-78278343.

Number of participants with anti-JNJ-78278343 antibodies will be assessed to evaluate the potential immunogenicity.

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.

Participants in one or more cohorts will receive JNJ-69086420 at the RP2D(s) determined in Part 1.

Participants will receive JNJ-69086420 at the determined RP2D(s) and fixed dose of JNJ-78278343.

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).

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).

City of Hope

University of Chicago

Tulane School Of Medicine

XCancer Omaha / Urology Cancer Center

Memorial Sloan Kettering Cancer Center

University of Utah Huntsman Cancer Institute

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.

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

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

Trials at a glance

Trials at a glance