A Phase 1 interventional study of JNJ-89402638 and Bevacizumab in Colorectal Neoplasms and Gastrointestinal Neoplasms, sponsored by Janssen Research & Development, LLC. Recruiting at 12 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
Among 2,338 studies in Colorectal Neoplasms with a site in United States — 420 open to participants now, 629 under way, 30 of them phase 3. Colorectal Neoplasms · United States.
Among the 2,338 studies in Colorectal Neoplasms with a site in United States, this one is the 461st largest by planned enrollment of the 1,931 interventional ones that give a count, is one of 124 that started in 2024, is one of 551 in phase 1, reaches primary completion later than 399 of the 627 other live ones, and was the 2,084th registered.
6,544 studies on the registry are indexed under Colorectal Neoplasms; 1,666 are open to participants now.
Browse Colorectal Neoplasms studies →420 of the 2,338 studies in Colorectal Neoplasms with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 18+
Exelixis · Sites in United States
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 40–80 · Men only
University of Pennsylvania · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,184 Colorectal Neoplasms studies recruiting now, 767 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 124 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,338 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 817 · Phase 2 790 · Phase 3 132 · Phase 4 19
First in 1981; this study’s year is marked. 124 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 260 is above the median of 76 across 4,801 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 64 across the 1,931 interventional studies, 221 across the 324 observational. Of the 1,562 that completed or were terminated, 548 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
885 of 2,338 have an industry lead sponsor. The 10 most frequent:
This study is registered under Janssen Research & Development, LLC, one of the names counted as Johnson & Johnson. Under that name alone:
Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Johnson & Johnson has 9 studies filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
227 of the studies in Colorectal Neoplasms with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05141721Phase 3Seattle Project CorporationA Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer | 2027-03 |
| NCT04428905Phase 3City of Hope Medical CenterSelf-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer | 2027-03-31 |
| NCT02997228Phase 3National Cancer Institute (NCI)Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study | 2027-06-01 |
| NCT01349881Phase 3SWOG Cancer Research NetworkS0820, Adenoma and Second Primary Prevention Trial | 2027-09-15 |
| NCT03796884Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityLinaclotide in Treating Patients With Stages 0-3 Colorectal Cancer | 2026-11 |
Add all 227 to your calendar (.ics) → With an account.
Among the 2,338 studies in Colorectal Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have evaluable or per (RECIST) version 1.1
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) and optimal route(s) of administration for JNJ-89402638 monotherapy have been identified.
Drug: JNJ-89402638
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1 as a monotherapy.
Drug: JNJ-89402638
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar.
Drug: JNJ-89402638 · Drug: Bevacizumab
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 along with bevacizumab or biosimilar and FOLFOX.
Drug: JNJ-89402638 · Drug: Bevacizumab · Drug: FOLFOX
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 in combination with bevacizumab or biosimilar and FOLFIRI.
Drug: JNJ-89402638 · Drug: Bevacizumab · Drug: FOLFIRI
Participants with metastatic gastric adenocarcinoma (mGAC) will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1.
Drug: JNJ-89402638
JNJ-89402638 will be administered.
Bevacizumab or biosimilar will be administered.
Chemotherapy agent FOLFOX will be administered.
Chemotherapy agent FOLFIRI will be administered.
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
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.
Time frame: From Baseline up to approximately 24 months
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities.
Time frame: From Baseline up to 28 days
Part 1 and Part 2: Serum Concentration for JNJ-89402638
Serum Concentration for JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638
Cmax of JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638
Cmin of JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638
Tmax of JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638
AUC of JNJ-89402638 will be reported.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-89402638 Antibodies
Participants with anti-JNJ-89402638 antibodies will be reported.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Overall Response (OR)
Overall response is best response of complete response (CR) or partial response (PR), assessed according to response evaluation criteria in solid tumors (RECIST) version 1.1.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Complete Response (CR)
Complete response is defined as a best response of CR assessed according to RECIST version 1.1.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Time to Response (TTR)
TTR is defined for participants who achieved an OR from the time of the first dose of study treatment to the first response of PR or better as assessed according to RECIST version 1.1.
Time frame: Up to approximately 24 months
Part 1 and Part 2: Duration of Response (DOR)
DOR is defined for participants who achieved an OR in the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death due to any cause, whichever occurs first, as assessed according to RECIST version 1.1
Time frame: Up to approximately 24 months
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Feb 2028, 40 months after the start.
Of 268 industry-sponsored phase 1 interventional studies under Colorectal Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 66. This study's planned 40 months is below that.
Counting every sponsor, half of 434 studies reached it within 48 months; a quarter within 31 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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