The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of Pasritamig in combination with JNJ-86974680 in Part 1 (Dose finding) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with advanced prostate cancer in Part 2 (Dose expansion) of study.

A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer

Prostatic Neoplasms

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-86974680

Pasritamig

A Phase 1b Study of Pasritamig (JNJ-78278343), a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-86974680, an A2a Receptor (A2aR) Antagonist, for 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. 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. Cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines and ocular events will be graded using the alternative scale provided in the protocol.

High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.

ORR is defined as the percentage of participants who have a partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version 1.1 response criteria without evidence of bone progression according to prostate cancer working group 3 (PCWG3).

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

DOR will be calculated among responders (PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first.

rPFS is defined as the time from the date of first dose of pasritamig or JNJ-86974680 until the date of radiographic disease progression or death, whichever comes first.

TTR is defined for the responders as the time from the date of first dose of any study treatment to the date of first documented response.

Serum samples will be analyzed to determine concentrations of pasritamig.

Plasma samples will be analyzed to determine concentrations of JNJ-86974680.

Serum samples will be analyzed for the detection of anti-pasritamig antibodies using a validated assay method.

Participants will receive pasritamig in combination with JNJ-86974680 to determine the recommended phase 2 combination dose (RP2CD) regimen.

Participants will receive pasritamig in combination with JNJ-86974680 at the RP2CD as determined in Part 1 of the study to confirm the safety and anti-tumor activity.

The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD)
of Pasritamig in combination with JNJ-86974680 in Part 1 (Dose finding) of the study and
to determine how safe and tolerable the RP2CD is for treatment of participants with
advanced prostate cancer in Part 2 (Dose expansion) of study.

Florida Cancer Specialists

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. 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. Cytokine release syndrome (CRS) and immune effector cell associated
neurotoxicity syndrome (ICANS) will be graded according to the American Society for
Transplantation and Cellular Therapy (ASTCT) guidelines and ocular events will be graded
using the alternative scale provided in the protocol.

High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities
leading to treatment discontinuation will be regarded as DLT.

ORR is defined as the percentage of participants who have a partial response (PR) or
better according to the response evaluation criteria in solid tumors (RECIST) version 1.1
response criteria without evidence of bone progression according to prostate cancer
working group 3 (PCWG3).

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

DOR will be calculated among responders (PR or better) from the date of initial
documentation of a response (PR or better) to the date of first documented evidence of
progressive disease, as defined in the PCWG3 or RECIST version 1.1 response criteria, or
death due to any cause, whichever occurs first.

rPFS is defined as the time from the date of first dose of pasritamig or JNJ-86974680
until the date of radiographic disease progression or death, whichever comes first.

TTR is defined for the responders as the time from the date of first dose of any study
treatment to the date of first documented response.

Serum samples will be analyzed for the detection of anti-pasritamig antibodies using a
validated assay method.

Participants will receive pasritamig in combination with JNJ-86974680 to determine the
recommended phase 2 combination dose (RP2CD) regimen.

Participants will receive pasritamig in combination with JNJ-86974680 at the RP2CD as
determined in Part 1 of the study to confirm the safety and anti-tumor activity.

A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer

Trials at a glance

Trials at a glance

A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer

Outcome measures

Primary outcome measures

Secondary outcome measures