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A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

This study is testing a new drug called JNJ-89402638 for people with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC). Metastatic means the cancer has spread. Researchers want to find the best dose of JNJ-89402638 and see how safe it is, both alone and when combined with other treatments like bevacizumab (or a similar drug), FOLFOX, or FOLFIRI chemotherapy. You might be able to join if you have mCRC that has gotten worse after at least two previous treatments, or if you have mGAC. The main goals are to track any side effects and how severe they are for up to 24 months. The study aims to enroll about 260 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is designed to find the best dose and assess the safety of JNJ-89402638.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Side effects will be measured for up to approximately 24 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06663319

A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

Recruiting
PHASE1Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~260 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:JNJ-89402638BevacizumabFOLFOXFOLFIRI

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
Measured over From Baseline up to approximately 24 months
+1 more outcome measured

Conditions

Colorectal Neoplasms
Gastrointestinal Neoplasms

Explore related trials

Colorectal AdenocarcinomaGastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

NCT06663319

Where you'd take part

This study runs at 12 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Asan Medical Center

    Seoul, South Koreano site contact published

    Recruiting

  • Community Health Network

    Indianapolis, Indianano site contact published

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Floridano site contact published

    Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, Spainno site contact published

    Recruiting

  • Hosp Univ Hm Sanchinarro

    Madrid, Spainno site contact published

    Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, Spainno site contact published

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, Spainno site contact published

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, South Koreano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Eligibility criteria

Inclusion

For Part 1 (dose escalation), Part 2 (Arm A \[JNJ-89402638 monotherapy\]): 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; For Part 2 Arm B (JNJ-89402638 + bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of CRC progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm C (JNJ-89402638 + FOLFOX/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting. Participants must have previously received a fluoropyrimidine and irinotecan doublet (such as FOLFIRI); For Part 2 Arm D (JNJ-89402638 + FOLFIRI/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of MSS or pMMR CRC progressing after 1 prior line of standard therapy in the metastatic/unresectable setting. Must not have received irinotecan previously for metastatic disease; For Part 2 Arm E (JNJ-89402638 monotherapy in mGAC): Have histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma progressing after 1 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
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

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). For Part 2 Arm C: Grade 2 or higher peripheral neuropathy is considered exclusionary
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

What this trial measures

  • Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by SeverityFrom Baseline up to approximately 24 months

    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 and Cellular Therapy (ASTCT) consensus.

  • Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)From Baseline up to 28 days

    The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities.