JNJ-89402638
DrugJNJ-89402638 will be administered.
NCT Number: NCT06663319
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Asan Medical Center, Seoul, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-89402638 will be administered.
Bevacizumab or biosimilar will be administered.
Chemotherapy agent FOLFOX will be administered.
Chemotherapy agent FOLFIRI will be administered.
Time frame: From Baseline up to approximately 24 months
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 28 days
The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities.
Time frame: Up to approximately 24 months
Serum Concentration for JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
Cmax of JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
Cmin of JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
Tmax of JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
AUC of JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
Participants with anti-JNJ-89402638 antibodies will be reported.
Time frame: Up to approximately 24 months
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
Complete response is defined as a best response of CR assessed according to RECIST version 1.1.
Time frame: Up to approximately 24 months
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
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
Contact information is provided by the study sponsor or research team.
Janssen Research & Development, LLC
Industry
A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07222800
Colonic Diseases, Colonic Neoplasms
Chandler, Arizona, United States
View Trial DetailsNCT03303495
Colonic Diseases, Colorectal Neoplasms
Guangzhou, Guangdong, China
View Trial DetailsNCT04084249
Colo-rectal Cancer, Colonic Cancer
Herlev, Capital Region of Denmark, Denmark
View Trial DetailsNCT03037385
Adenocarcinoma, Adenocarcinoma, Papillary
Phoenix, Arizona, United States
View Trial Details