A Study of JNJ-89402638 for Metastatic Colorectal Cancer
NCT ID: NCT06663319
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
170 participants
INTERVENTIONAL
2024-10-15
2028-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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JNJ-89402638
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.
JNJ-89402638
JNJ-89402638 will be administered.
Interventions
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JNJ-89402638
JNJ-89402638 will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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University of Colorado Denver Anschultz Medical Campus
Aurora, Colorado, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Community Health Network
Indianapolis, Indiana, United States
Start Midwest
Grand Rapids, Michigan, United States
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp Univ Fund Jimenez Diaz
Madrid, , Spain
Hosp Univ Hm Sanchinarro
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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89402638GIC1001
Identifier Type: OTHER
Identifier Source: secondary_id
2024-516526-66-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
89402638GIC1001
Identifier Type: -
Identifier Source: org_study_id