New drug JNJ-89402638 enters human trials for Tough-to-Treat GI cancers
NCT ID NCT06663319
First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 4 times
Summary
This early-phase study is testing an experimental drug called JNJ-89402638 in people with metastatic colorectal or gastric cancer that has progressed after at least two prior treatments. The trial will first find the safest dose and schedule, then test the drug alone or combined with standard chemotherapy and/or bevacizumab. About 260 participants will be enrolled to monitor side effects and measure drug levels in the blood.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JNJ-89402638 (an experimental drug) given alone or with bevacizumab and/or chemotherapy (FOLFOX or FOLFIRI)
- What this could lead to
- If this trial succeeds, it could point toward a new treatment option for people with advanced colorectal or gastric cancer who have run out of standard therapies.
- What could go wrong
- This is a very early Phase 1 study focused on safety and dosing, not on proving the drug works. Many experimental cancer drugs fail in early testing, and side effects like cytokine release syndrome are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 260 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2024
- Expected to finish
-
Jul 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Colorectal neoplasms are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
12 sites in 3 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
-
Community Health Network
RECRUITINGIndianapolis, Indiana, 46256, United States
-
Florida Cancer Specialists
RECRUITINGSarasota, Florida, 34232, United States
-
Hosp Univ Fund Jimenez Diaz
RECRUITINGMadrid, 28040, Spain
-
Hosp Univ Hm Sanchinarro
RECRUITINGMadrid, 28050, Spain
-
Hosp Univ Vall D Hebron
RECRUITINGBarcelona, 08035, Spain
-
Hosp. Univ. 12 de Octubre
RECRUITINGMadrid, 28041, Spain
-
Severance Hospital Yonsei University Health System
RECRUITINGSeoul, 03722, South Korea
-
Start Midwest
RECRUITINGGrand Rapids, Michigan, 49546, United States
-
Swedish Cancer Institute
RECRUITINGSeattle, Washington, 98104, United States
-
University of Arizona Cancer Center
RECRUITINGTucson, Arizona, 85719, United States
-
University of Colorado Denver Anschultz Medical Campus
RECRUITINGAurora, Colorado, 80045, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental drug velzatinib offered to GIST patients who have run out of options
- New drug trio takes aim at HER2-Positive stomach cancer
- Muscle loss may predict who struggles after cancer surgery
- Radioactive antibody aims to light up hidden solid tumors
- AI reads tumor slides to match cancer patients with trials
- Targeted drug combo takes aim at hard-to-treat KRAS-mutant colorectal cancer