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NCT06663319From ClinicalTrials.govRecruiting

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

A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies

  • Colorectal Neoplasms
  • Gastrointestinal Neoplasms

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
260
Started
15 October 2024
Main results due
25 February 2028
Study sites
12
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* 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

  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). 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 study is about

In the sponsor’s own words, from the registry.

The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) and best way to take (optimal route of administration) 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.

Study sites(12)

  • University of Arizona Cancer Center

    Tucson, Arizona, United States

    Recruiting

  • University of Colorado Denver Anschultz Medical Campus

    Aurora, Colorado, United States

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida, United States

    Recruiting

  • Community Health Network

    Indianapolis, Indiana, United States

    Recruiting

  • Start Midwest

    Grand Rapids, Michigan, United States

    Recruiting

  • Swedish Cancer Institute

    Seattle, Washington, United States

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, South Korea

    Recruiting

  • Asan Medical Center

    Seoul, South Korea

    Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, Spain

    Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, Spain

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, Spain

    Recruiting

  • Hosp Univ Hm Sanchinarro

    Madrid, Spain

    Recruiting

Showing 12 of 12 sites. 12 of the 12 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06663319. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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