JNJ-89402638 for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Janssen Research & Development, LLC

Must not be taking: Glucocorticoids, Live vaccines

Disqualifiers: Brain metastases, Second malignancy, others

No Placebo Group

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.

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

+3 more

Trial 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

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: JNJ-89402638Experimental Treatment1 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.