The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants with advanced solid tumors in Part 2.

A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors

Colorectal Neoplasms

Metastatic Colorectal Cancer

Colorectal cancer

Anal cancer

Colon cancer

Rectal cancer

Gastrointestinal Cancer

Advanced Solid Tumors

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

JNJ-95437446

A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors

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.

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

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

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

PFS is defined as the time from the first dose of JNJ-95437446 to either progressive disease (PD) or death due to any cause, whichever comes first.

Serum samples will be analyzed to determine Cmax of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite.

Tmax defined as the the time to reach maximum observed plasma concentration of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite will be reported.

AUC (0-t) defined as area under the plasma concentration-time curve during a dosing interval of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite will be reported.

Serum samples will be analyzed for the detection of anti-JNJ-95437446 antibodies using a validated assay method.

Participants will receive JNJ-95437446 in Part 1 until at least two recommended phase 2 doses (RP2Ds) has been developed. Participants in Part 2 will receive JNJ-95437446 at the RP2Ds developed in Part 1.

The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of
JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants
with advanced solid tumors in Part 2.

Florida Cancer Specialists

NEXT Oncology

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.

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

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

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

PFS is defined as the time from the first dose of JNJ-95437446 to either progressive
disease (PD) or death due to any cause, whichever comes first.

Serum samples will be analyzed to determine Cmax of JNJ-95437446 antibody-drug conjugate,
total antibody, released payload and the payload's metabolite.

Tmax defined as the the time to reach maximum observed plasma concentration of
JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's
metabolite will be reported.

AUC (0-t) defined as area under the plasma concentration-time curve during a dosing
interval of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and
the payload's metabolite will be reported.

Serum samples will be analyzed for the detection of anti-JNJ-95437446 antibodies using a
validated assay method.

Participants will receive JNJ-95437446 in Part 1 until at least two recommended phase 2
doses (RP2Ds) has been developed. Participants in Part 2 will receive JNJ-95437446 at the
RP2Ds developed in Part 1.

A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors

Trials at a glance

Trials at a glance

A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors

Outcome measures

Primary outcome measures

Secondary outcome measures