Clinical trial for Colorectal Neoplasms
Official title A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers
ClinicalTrials.gov ID: NCT06663319
What this study is testing
What is JNJ-89402638?
JNJ-89402638 is an investigational medicine being studied as a potential treatment for metastatic colorectal and gastric cancers.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing the best dose and way to give a new drug. It also checks how safe the drug is alone or with other treatments.
- Who it's for
- You may be able to join if you have advanced colon or stomach cancer.
- What's involved
- You would get the new drug, possibly with other medicines. The team will watch for side effects and how well it works.
- Time commitment
- The study lasts as long as needed to check safety and find the right dose.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For Part 1 (dose escalation), Part 2 (Arm A [JNJ-89402638 monotherapy]): Have histologically or cytologically confirmed diagnosis of colorectal...
- Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1
- Part 1: Must have either measurable or evaluable disease
- Part 2: Must have at least 1 measurable lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
You likely can't join if
- 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...
- Has a prior or concurrent second malignancy (other than the disease under study) unless natural history or treatment is unlikely to interfere with...
- 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...
See the full eligibility criteria
- For Part 1 (dose escalation), Part 2 (Arm A [JNJ-89402638 monotherapy]): Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard...
- Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1
- Part 1: Must have either measurable or evaluable disease
- 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...
- 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 how well it works of the study...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- Aurora, Colorado, United States
- Sarasota, Florida, United States
- Indianapolis, Indiana, United States
- Grand Rapids, Michigan, United States
- Seattle, Washington, United States
- Seoul, South Korea
- Barcelona, Spain
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States; Aurora, Colorado, United States; Sarasota, Florida, United States; Indianapolis, Indiana, United States; Grand Rapids, Michigan, United States; Seattle, Washington, United States and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.