The purpose of this study is to determine safe and effective dose (recommended phase 2 doses [RP2Ds]) of JNJ-89862175 in Part 1 (dose escalation), and to further evaluate how safe JNJ-89862175 is at the RP2Ds in Part 2 (dose expansion) in participants with advanced stage solid tumors.

A Study of JNJ-89862175 for Treatment of Advanced Solid Tumors

Advanced-stage Solid Tumors

JNJ-89862175

A Phase 1 Study of JNJ-89862175, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 Antibody Drug Conjugate, for Advanced Solid Tumors

The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation.

An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention. 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.

An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention. Severity will be graded according to the 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.

ORR is defined as the percentage of participants who have best overall response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v.) 1.1.

PFS is defined as the time from the first dose of JNJ-89862175 to either disease progression according to RECIST v. 1.1, or death due to any cause, whichever comes first.

DOR is defined as the time from the date of initial documentation of a response to the date of first documented evidence of disease progression according to RECIST v. 1.1, or death due to any cause, whichever occurs first.

Serum samples will be analyzed to determine Cmax of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite.

Ctrough of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported.

Tmax defined as the the time to reach maximum observed plasma concentration of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported.

AUC (0-t) defined as area under the plasma concentration-time curve during a dosing interval of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported.

Accumulation ratio of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported.

Serum samples will be analyzed for the detection of anti-JNJ-89862175 antibodies using a validated assay method.

Participants will receive JNJ-89862175 in Part 1 to determine the recommended phase 2 doses (RP2Ds). Dose-escalation and de-escalation will be based on study evaluation team (SET) decision. In Part 2, participants will receive JNJ-89862175 at the RP2Ds determined in Part 1.

The purpose of this study is to determine safe and effective dose (recommended phase 2
doses [RP2Ds]) of JNJ-89862175 in Part 1 (dose escalation), and to further evaluate how
safe JNJ-89862175 is at the RP2Ds in Part 2 (dose expansion) in participants with
advanced stage solid tumors.

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NEXT Oncology

The DLTs are specific adverse events that includes high grade hematologic or
non-hematologic toxicities with exceptions and/or toxicities leading to treatment
discontinuation.

An AE is any untoward medical occurrence in a clinical study participant administered a
pharmaceutical (investigational or non-investigational) product and does not necessarily
have a causal relationship with the intervention. 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.

An AE is any untoward medical occurrence in a clinical study participant administered a
pharmaceutical (investigational or non-investigational) product and does not necessarily
have a causal relationship with the intervention. Severity will be graded according to
the 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.

ORR is defined as the percentage of participants who have best overall response of
complete response (CR) or partial response (PR) according to response evaluation criteria
in solid tumors (RECIST) version (v.) 1.1.

PFS is defined as the time from the first dose of JNJ-89862175 to either disease
progression according to RECIST v. 1.1, or death due to any cause, whichever comes first.

DOR is defined as the time from the date of initial documentation of a response to the
date of first documented evidence of disease progression according to RECIST v. 1.1, or
death due to any cause, whichever occurs first.

Serum samples will be analyzed to determine Cmax of JNJ-89862175 with total and
conjugated antibody, free payload and major metabolite.

Ctrough of JNJ-89862175 with total and conjugated antibody, free payload and major
metabolite will be reported.

Tmax defined as the the time to reach maximum observed plasma concentration of
JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will
be reported.

AUC (0-t) defined as area under the plasma concentration-time curve during a dosing
interval of JNJ-89862175 with total and conjugated antibody, free payload and major
metabolite will be reported.

Accumulation ratio of JNJ-89862175 with total and conjugated antibody, free payload and
major metabolite will be reported.

Serum samples will be analyzed for the detection of anti-JNJ-89862175 antibodies using a
validated assay method.

Participants will receive JNJ-89862175 in Part 1 to determine the recommended phase 2
doses (RP2Ds). Dose-escalation and de-escalation will be based on study evaluation team
(SET) decision. In Part 2, participants will receive JNJ-89862175 at the RP2Ds determined
in Part 1.

A Study of JNJ-89862175 for Treatment of Advanced Solid Tumors

Trials at a glance

Trials at a glance

A Study of JNJ-89862175 for Treatment of Advanced Solid Tumors

Outcome measures

Primary outcome measures

Secondary outcome measures