A Study of JNJ-89402638 for Metastatic Colorectal 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.

Conditions

Unresectable Metastatic Colorectal Cancer

Study Overview

Study Details

Study overview

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

A Study of JNJ-89402638 for Metastatic Colorectal Cancer

Condition
Unresectable Metastatic Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Sarasota

Florida Cancer Specialists, Sarasota, Florida, United States, 34232

Grand Rapids

Start Midwest, Grand Rapids, Michigan, United States, 49546

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

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

Study Record Dates

2028-07-19