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NCT06663319 · ClinicalTrials.gov registry record · Phase 1
A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers
A Phase 1 study of Colorectal Neoplasms and Gastrointestinal Neoplasms, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 220
- Enrollment target
- 9
- Study locations
NCT06663319: Recruiting Phase 1 study of Colorectal Neoplasms and Gastrointestinal Neoplasms, sponsored by Janssen Research & Development.
NCT06663319 is a Phase 1 study of Colorectal Neoplasms and Gastrointestinal Neoplasms that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 220 participants, below the 572-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (62% lower). The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06663319, a Phase 1 study of Colorectal Neoplasms and Gastrointestinal Neoplasms, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 220 participants
- Enrollment target
- 9
- Study locations
Study 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 (mCRC) and metastatic gastric cancer (mGAC) and to determine the safety and tolerability of JNJ-89402638 in combination with bevacizumab or biosimilar with or without chemotherapy in participants with mCRC.
Primary Outcome
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded per American Society for Transplantation
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG FOLFIRI
- DRUG FOLFOX
- DRUG JNJ-89402638
Study Locations (9)
Other
- Hosp Univ Vall D Hebron - Barcelona
- Hosp Univ Fund Jimenez Diaz - Madrid
- Hosp. Univ. 12 de Octubre - Madrid
- Hosp Univ Hm Sanchinarro - Madrid
Colorado
- University of Colorado Denver Anschultz Medical Campus - Aurora
Florida
- Florida Cancer Specialists - Sarasota
Indiana
- Community Health Network - Indianapolis
Michigan
- Start Midwest - Grand Rapids
Washington
- Swedish Cancer Institute - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2024-10-15 |
| Est. Completion | 2028-07-19 |
| Phase | Phase 1 |
What NCT06663319 shows while recruiting
NCT06663319 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 572-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (62% lower).
The record links to 2 conditions, with Colorectal Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Bevacizumab is the first listed.
NCT06663319 lists 9 locations in 6 states (Other, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT06663319 about?
NCT06663319 is a clinical study titled "A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers". 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 (mCRC) and metastatic gastric cancer (mGAC) and to determine the safety and tolerabi...
What is the current status of trial NCT06663319?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2024-10-15. Estimated completion is 2028-07-19.
What conditions does trial NCT06663319 study?
This clinical trial studies the following conditions: Colorectal Neoplasms, Gastrointestinal Neoplasms.
What interventions are being tested in trial NCT06663319?
The interventions under investigation include: Bevacizumab (DRUG), FOLFIRI (DRUG), FOLFOX (DRUG), JNJ-89402638 (DRUG).
Who is sponsoring clinical trial NCT06663319?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06663319 being conducted?
This trial has 9 study locations across Colorado, Florida, Indiana, Michigan, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06663319's enrollment target sits among peer trials
220 31st of 54 higher than 24 of 54 other Colorectal Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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