JNJ-89402638 for Colorectal Cancer

Recruiting at 5 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

120 Participants Needed

Trial Summary

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.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires