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A Study of JNJ-89402638 for Metastatic Colorectal Cancer

Last Updated   June 18, 2025

Want to learn how to participate in this trial?

89402638GIC1001

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 1
  • Sites
    8 Sites
  • Status
    Recruiting

SUMMARY

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.

CONDITIONS

  • Unresectable Metastatic Colorectal Cancer

ELIGIBILITY


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
2. 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


Exclusion Criteria:

* 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 replacement)
* 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 efficacy of the study treatment
* 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


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 crit

More...

DETAILS

LOCATIONS

Locations in:
United States, South Korea, Spain
Country (3) City or Province (8) Status
United States Sarasota Florida Cancer Specialists
RECRUITING
United States Grand Rapids Start Midwest
RECRUITING
United States Aurora University of Colorado Denver Anschultz Medical Campus
RECRUITING
United States Indianapolis Community Health Network
RECRUITING
South Korea Seoul Severance Hospital Yonsei University Health System
SUSPENDED
South Korea Seoul Asan Medical Center
SUSPENDED
Spain Madrid Hosp Univ Hm Sanchinarro
RECRUITING
Spain Barcelona Hosp Univ Vall D Hebron
RECRUITING
Show More
Geo Locations

27.33643, -82.53065

42.96336, -85.66809

39.72943, -104.83192

39.76838, -86.15804

37.566, 126.9784

37.566, 126.9784

40.4165, -3.70256

41.38879, 2.15899

x
50

Indicates 50+ sites in this region: click to zoom in.

10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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