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Trial Title:
A Study of JNJ-89402638 for Metastatic Colorectal Cancer
NCT ID:
NCT06663319
Condition:
Unresectable Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JNJ-89402638
Description:
JNJ-89402638 will be administered.
Arm group label:
JNJ-89402638
Summary:
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Start Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Start date:
October 28, 2024
Completion date:
July 19, 2028
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06663319
