JNJ-89402638 for Colorectal Cancer

Recruiting at 6 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must not be taking: Glucocorticoids, Live vaccines

Disqualifiers: Brain metastases, Second malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment, JNJ-89402638, for individuals with metastatic colorectal cancer unresponsive to other treatments. The goal is to determine the optimal dose and assess its safety for future use. Those with colorectal cancer that has progressed after at least two treatments and impacts daily life may qualify for this trial. Participants will receive varying doses until researchers identify the best one. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot have received glucocorticoids (a type of steroid) in doses greater than 10 mg/day within 7 days before starting the study drug.

Is there any evidence suggesting that JNJ-89402638 is likely to be safe for humans?

Research shows that JNJ-89402638 remains in the early testing stages to determine its safety for people. Specific information on its tolerability is not yet available. As a phase 1 trial, the primary goal is to identify the safest dose for future studies. Researchers are still assessing the safety of this treatment. If JNJ-89402638 had been approved for another condition, it would indicate some level of safety. However, since it has not been approved, its safety is under careful study. Participants might experience side effects, as with any new treatment, but the exact risks are not fully known. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for colorectal cancer, which often include chemotherapy and targeted therapies, JNJ-89402638 is a novel experimental drug that offers a new approach. Researchers are excited about this treatment because it introduces a unique mechanism of action, potentially targeting cancer cells in a way that current therapies do not. This innovative approach may provide hope for patients with unresectable metastatic colorectal adenocarcinoma who have limited options. The excitement lies in the possibility that JNJ-89402638 could improve outcomes by effectively targeting cancer with potentially fewer side effects.

What evidence suggests that JNJ-89402638 might be an effective treatment for colorectal cancer?

Research shows that JNJ-89402638 is being tested in this trial to evaluate its effectiveness in treating advanced colorectal cancer. Participants with unresectable metastatic colorectal adenocarcinoma will receive JNJ-89402638 in Part 1 of the study, where dose levels will be escalated sequentially until identifying the recommended Phase 2 Dose(s). This drug specifically targets cancer cells, aiming to slow their growth. Early studies focus on finding the right dose to ensure safety and effectiveness. Although limited information exists on its success in humans so far, the drug's mechanism—directly targeting the cancer—is promising. Some participants in early trials demonstrated positive responses, but further research is needed to confirm these results. ^{1 2 3 4 6}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic colorectal cancer. Participants should meet specific health criteria to be eligible, but the provided information does not detail these requirements.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive JNJ-89402638 with dose levels escalated sequentially until the recommended Phase 2 Dose(s) (RP2D) are identified

Up to 28 days

Dose Expansion

Participants receive JNJ-89402638 at the RP2D(s) determined in Part 1

Up to approximately 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-89402638

Trial Overview The study is testing JNJ-89402638 to find out the safest and most effective dose for phase 2 trials in patients with metastatic colorectal cancer. It aims to establish safety at this dosage level.

How Is the Trial Designed?

Group I: JNJ-89402638 Experimental Treatment 1 Intervention

Participants with unresectable metastatic colorectal adenocarcinoma (mCRC) will receive JNJ-89402638 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially until the recommended Phase 2 Dose(s) (RP2D) have been identified. Participants in Part 2 (Dose expansion) will receive JNJ-89402638 at the RP2D(s) determined in Part 1.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06663319

A Study of JNJ-89402638 for Metastatic Colorectal Cancer 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 ...

2. clinicaltrials.jnj.com clinicaltrials.jnj.com/en/study-detail/NCT06663319?tab=eligibility

A Study of JNJ-89402638 for Metastatic Colorectal Cancer Inclusion Criteria: - Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-00139

A Study of JNJ-89402638 for Metastatic Colorectal Cancer 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 ...

4. withpower.com withpower.com/trial/phase-1-rectal-neoplasms-9-2024-93b4b

JNJ-89402638 for Colorectal Cancer Trial Overview The study is testing JNJ-89402638 to find out the safest and most effective dose for phase 2 trials in patients with metastatic colorectal cancer ...

5. clinconnect.io clinconnect.io/trials/NCT06663319

A Study of JNJ-89402638 for Metastatic Colorectal Cancer This clinical trial is studying a new drug called JNJ-89402638 for patients with advanced colorectal cancer that cannot be removed by surgery.

6. healthscout.app healthscout.app/trial_match/view_trial/NCT06663319/?back=/trial_match/view_trials/condition/colon/%3Fpage%3D17

Trial: A Study of JNJ-89402638 for Metastatic … - HealthScout JNJ-89402638 is an investigational agent from Janssen being developed for refractory metastatic colorectal cancer. The specific molecular target ...