The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) and best way to take (optimal route of administration) 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
JNJ-89402638 will be administered.
Bevacizumab or biosimilar will be administered.
Chemotherapy agent FOLFOX will be administered.
Chemotherapy agent FOLFIRI will be administered.
University of Arizona Cancer Center
Tucson, Arizona, United States
RECRUITINGUniversity of Colorado Denver Anschultz Medical Campus
Aurora, Colorado, United States
RECRUITINGFlorida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGCommunity Health Network
Indianapolis, Indiana, United States
RECRUITINGStart Midwest
Grand Rapids, Michigan, United States
RECRUITINGSwedish Cancer Institute
Seattle, Washington, United States
RECRUITINGSeverance Hospital Yonsei University Health System
Seoul, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGHosp Univ Vall D Hebron
Barcelona, Spain
RECRUITINGHosp Univ Fund Jimenez Diaz
Madrid, Spain
RECRUITING...and 2 more locations
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
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.
Time frame: From Baseline up to approximately 24 months
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities.
Time frame: From Baseline up to 28 days
Part 1 and Part 2: Serum Concentration for JNJ-89402638
Serum Concentration for JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638
Cmax of JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638
Cmin of JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638
Tmax of JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638
AUC of JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-89402638 Antibodies
Participants with anti-JNJ-89402638 antibodies will be reported.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Overall Response (OR)
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.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Complete Response (CR)
Complete response is defined as a best response of CR assessed according to RECIST version 1.1.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Time to Response (TTR)
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.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Duration of Response (DOR)
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
Time frame: Up to approximately 24 months
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