The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of
pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety
at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose
expansion).

A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

Metastatic Castration-resistant Prostate Neoplasms

Metastatic Castration-resistant Prostate Cancer

Metastatic Prostate Cancer

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Genitourinary Cancer

Advanced Solid Tumors

Prostate Neoplasms

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

Metastatic Hormone-sensitive Prostate Cancer

Apalutamide

Cetrelimab

Docetaxel

Cabazitaxel

Enzalutamide

Darolutamide

Abiraterone acetate plus prednisone (AAP)

Pasritamig

Lutetium Lu-177 vipivotide tetraxetan

JNJ-101556143

A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer

DLTs are specific adverse events and are defined as any of the following: high grade
non-hematologic toxicity or hematologic toxicity.

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. Severity will be graded according to the
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector
cell-associated neurotoxicity syndrome events, which will be graded by American Society
for Transplantation and Cellular Therapy (ASTCT) guidelines. 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.

ORR is defined as the percentage of participants who have a partial response (PR) or
better without evidence of bone progression according to Prostate Cancer Working Group 3
(PCWG3) criteria.

PSA response rate is defined as the percentage of participants with a confirmed decline
of PSA of 50 percent (%) or more from baseline.

rPFS is defined time from the date of first dose of pasritamig until the date of
objective disease progression or death, whichever comes first.

TTR is defined for the responders as the time from the date of first dose of to the date
of first documented response that is subsequently confirmed.

DOR is defined for participants who achieved response (PR or better) as the time between
the date of initial documentation of response (PR or better) to the date of first
documented evidence of progressive disease, as defined in the PCWG3, or death due to any
cause, whichever occurs first.

Composite PFS is defined as time from start of treatment to the date of first occurrence
of investigator determined disease progression (Response Evaluation Criteria in Solid
Tumors [RECIST] or bone progression), pain, PSA progression, death or last disease
assessment.

Participants will receive pasritamig (JNJ-78278343) and combination agent (cetrelimab,
cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus
prednisone, Lutetium Lu-177 vipivotide tetraxetan and JNJ-101556143) during Part 1 (dose
escalation). The dose of pasritamig (JNJ-78278343) will be escalated sequentially until a
recommended phase 2 regimen (RP2R). Participants will receive pasritamig (JNJ-78278343)
and combination agent treatment at the putative RP2R in Part 2 (dose expansion).

The purpose of this study is to identify the recommended phase 2 doses (RP2Ds) of
      JNJ-78278343 with cetrelimab (JNJ-63723283) in Part 1 (dose escalation) and to determine
      safety at the RP2D(s) in Part 2 (dose expansion).

A Study of JNJ-78278343 in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer

Florida Cancer Specialists

Start Midwest

Macquarie University

Peter MacCallum Cancer Centre

Princess Alexandra Hospital

A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer

DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.

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. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. 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.

ORR is defined as the percentage of participants who have a partial response (PR) or better without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3) criteria.

PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline.

DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first.

Participants will receive subcutaneous (SC) administration of JNJ-78278343 in combination with intravenous (IV) infusion of cetrelimab during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 dose (RP2D). Participants will receive the combination treatment at the RP2D in Part 2 (dose expansion)

A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

Trials at a glance

Trials at a glance

A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

Outcome measures

Primary outcome measures

Secondary outcome measures