170 Participants Needed

JNJ-89402638 for Colorectal Cancer

Recruiting at 5 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Who Is on the Research Team?

JR

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
See 3 more

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?
1Treatment groups
Experimental Treatment
Group I: JNJ-89402638Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

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 profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

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

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