A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies
A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers
Hagiwara Akiko
Janssen Pharmaceutical K.K.
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
+81-120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Medical Information Center
Janssen Pharmaceutical K.K.
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
+81-120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Pending
Dec. 04, 2026
260
Interventional
non-randomized controlled trial
open(masking not used)
uncontrolled control
parallel assignment
treatment purpose
- 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 line of standard therapy in the metastatic/unresectable setting. Must not have received oxaliplatin previously for metastatic disease;
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
(a) Part 1: Must have either measurable or evaluable disease
(b) 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
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
18age old over
No limit
Both
Colorectal Neoplasms, Gastrointestinal Neoplasms
Arms:
Experimental: Part 1 (Dose Expansion)
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.
Experimental: Part 2 (Dose Expansion): Arm A
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) and route as determined in Part 1 as a monotherapy.
Experimental: Part 2 (Dose Expansion): Arm B
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined
in Part 1 along with bevacizumab or biosimilar.
Experimental: Part 2 (Dose Expansion): Arm C
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined
in Part 1 along with bevacizumab or biosimilar and FOLFOX.
Experimental: Part 2 (Dose Expansion): Arm D
Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 in combination with bevacizumab or biosimilar and FOLFIRI.
Experimental: Part 2 (Dose Expansion): Arm E
Participants with metastatic gastric adenocarcinoma (mGAC) will receive JNJ-89402638 at the RP2D and route as determined in Part 1.
Assigned Interventions:
Drug: JNJ-89402638
JNJ-89402638 will be administered.
Drug: Bevacizumab
Bevacizumab or biosimilar will be administered.
Drug: FOLFOX
Chemotherapy agent FOLFOX will be administered.
Drug: FOLFIRI
Chemotherapy agent FOLFIRI will be administered.
1. 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
2. Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
The DLTs are specific adverse events including high grade hematologic or nonhematologic toxicities.
Time Frame: From Baseline up to 28 days
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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
12. 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
Janssen Pharmaceutical K.K.
Aichi Cancer Center Institutional Review Board
1-1 Kanokoden, Chikusa-ku Nagoya, Aichi
+81-52-762-6111
Approval
May. 21, 2026
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
