RECRUITING

A Study of JNJ-89402638 for Metastatic Colorectal Cancer

Conditions

Unresectable Metastatic Colorectal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer

Quick Facts

Study Start:2024-10-15

Study Completion:2028-07-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06663319

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting * Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1 1. Part 1: Must have either measurable or evaluable disease 2. Part 2: Must have at least 1 measurable lesion * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Have an estimated or measured glomerular filtration rate (GFR) greater than or equal to (\>=) 30 milliliter per minute (mL/min) based on modification of diet in renal disease (MDRD) 4-variable formula	* Active (new or progressive) brain metastases, leptomeningeal disease, or untreated spinal cord compression * Toxicity from prior anticancer therapy that has not resolved to Grade less than or equal to (\<=)1 (except alopecia, vitiligo, Grade \<= 2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement) * Has a prior or concurrent second malignancy (other than the disease under study) unless natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment * Received glucocorticoids (doses \>10 mg/day prednisone or equivalent) within 7 days prior to the first dose of study drug * Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment or within 4 weeks after the last dose of study treatment

Inclusion Criteria

Exclusion Criteria

* Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting
* Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1
1. Part 1: Must have either measurable or evaluable disease
2. Part 2: Must have at least 1 measurable lesion
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Have an estimated or measured glomerular filtration rate (GFR) greater than or equal to (\>=) 30 milliliter per minute (mL/min) based on modification of diet in renal disease (MDRD) 4-variable formula

* Active (new or progressive) brain metastases, leptomeningeal disease, or untreated spinal cord compression
* Toxicity from prior anticancer therapy that has not resolved to Grade less than or equal to (\<=)1 (except alopecia, vitiligo, Grade \<= 2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement)
* Has a prior or concurrent second malignancy (other than the disease under study) unless natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
* Received glucocorticoids (doses \>10 mg/day prednisone or equivalent) within 7 days prior to the first dose of study drug
* Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment or within 4 weeks after the last dose of study treatment

Contacts and Locations

Study Contact

CONTACT

844-434-4210

Participate-In-This-Study@its.jnj.com

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

STUDY_DIRECTOR

Janssen Research & Development, LLC

Study Locations (Sites)

Florida Cancer Specialists

Sarasota, Florida, 34232

United States

Start Midwest

Grand Rapids, Michigan, 49546

United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-15

Study Completion Date2028-07-19

Study Record Updates

Study Start Date2024-10-15

Study Completion Date2028-07-19

Terms related to this study

Additional Relevant MeSH Terms

Unresectable Metastatic Colorectal Cancer