A Study of JNJ-89402638 for Metastatic Colorectal Cancer

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Oct 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called JNJ-89402638 for patients with advanced colorectal cancer that cannot be removed by surgery. The main goal is to find out the safest dose of this drug and how effective it is in treating this type of cancer after patients have already tried two or more other treatments.

To participate in this study, patients need to have a confirmed diagnosis of colorectal cancer that is getting worse despite previous treatments, and they should have measurable signs of the disease. They should also be in good enough overall health to participate, meaning they can carry out normal daily activities with minimal assistance. During the trial, participants will receive the study drug and will be monitored closely for any side effects and how well the treatment is working. This trial is currently open for enrollment and welcomes participants of all genders aged 65 and older. If you or a loved one meet the eligibility criteria, this may be an opportunity to explore a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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