The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) of JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC) and to determine the safety and tolerability of JNJ-89402638 in combination with bevacizumab or biosimilar with or without chemotherapy in participants with mCRC.

A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

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

Gastrointestinal Neoplasms

JNJ-89402638

Bevacizumab

FOLFOX

FOLFIRI

A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies

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 of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus.

The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities.

Serum Concentration for JNJ-89402638 will be reported.

Participants with anti-JNJ-89402638 antibodies will be reported.

Overall response is best response of complete response (CR) or partial response (PR), assessed according to response evaluation criteria in solid tumors (RECIST) version 1.1.

Complete response is defined as a best response of CR assessed according to RECIST version 1.1.

TTR is defined for participants who achieved an OR from the time of the first dose of study treatment to the first response of PR or better as assessed according to RECIST version 1.1.

DOR is defined for participants who achieved an OR in the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death due to any cause, whichever occurs first, as assessed according to RECIST version 1.1

Participants with unresectable metastatic colorectal adenocarcinoma (mCRC) will receive JNJ-89402638 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially until the recommended Phase 2 Dose(s) (RP2D) for JNJ-89402638 monotherapy have been identified.

Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 as a monotherapy.

Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar.

Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar and FOLFOX.

Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 in combination with bevacizumab or biosimilar and FOLFIRI.

Participants with metastatic gastric adenocarcinoma (mGAC) will receive JNJ-89402638 at the RP2D determined in Part 1.

The purpose of this study is to determine the putative recommended phase 2 dose(s)
(RP2Ds) of JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in
participants with metastatic colorectal cancer.

A Study of JNJ-89402638 for Metastatic Colorectal Cancer

University of Colorado Denver Anschultz Medical Campus

Florida Cancer Specialists

Community Health Network

Start Midwest

Severance Hospital Yonsei University Health System

Asan Medical Center

Hosp Univ Vall D Hebron

Hosp Univ Hm Sanchinarro

A Phase I Study of JNJ-89402638 for Unresectable Metastatic Colorectal 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 of AEs will be graded according to
the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated
neurotoxicity syndrome (ICANS) will be graded per American Society for Transplantation
and Cellular Therapy (ASTCT) consensus.

The DLTs are specific adverse events including high grade hematologic or non-hematologic
toxicities.

Overall response is best response of complete response (CR) or partial response (PR),
assessed according to response evaluation criteria in solid tumors (RECIST) version 1.1.

Complete response is defined as a best response of CR assessed according to RECIST
version 1.1.

TTR is defined for participants who achieved an OR from the time of the first dose of
study treatment to the first response of PR or better as assessed according to RECIST
version 1.1.

DOR is defined for participants who achieved an OR in the time between the date of
initial documentation of first response of PR or better to the date of first documented
evidence of progressive disease or death due to any cause, whichever occurs first, as
assessed according to RECIST version 1.1

Participants with unresectable metastatic colorectal adenocarcinoma (mCRC) will receive
JNJ-89402638 in Part 1 (Dose escalation) of the study and the dose levels will be
escalated sequentially until the recommended Phase 2 Dose(s) (RP2D) have been identified.
Participants in Part 2 (Dose expansion) will receive JNJ-89402638 at the RP2D(s)
determined in Part 1.

A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

Trials at a glance

Trials at a glance