Recruiting
Phase 1

JNJ-89402638

Sponsor:

Janssen Research & Development, LLC

Code:

NCT06663319

Conditions

Colorectal Neoplasms

Gastrointestinal Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-89402638

Bevacizumab

FOLFOX

FOLFIRI

Study Details

Brief summary:

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.

Conditions

Colorectal Neoplasms

Gastrointestinal Neoplasms

Study ID

NCT06663319

Start date

Oct 15, 2024

Status verified date

Aug, 2026

Completion date

Jul 19, 2028

Anticipated

Primary completion date

Feb 25, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

260 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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(s) and route as determined in Part 1.

Interventions

JNJ-89402638

JNJ-89402638 will be administered.

Bevacizumab

Bevacizumab or biosimilar will be administered.

FOLFOX

Chemotherapy agent FOLFOX will be administered.

FOLFIRI

Chemotherapy agent FOLFIRI will be administered.

Primary outcome measure

  • Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity [ Time Frame: From Baseline up to approximately 24 months ]
  • Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: From Baseline up to 28 days ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85719

University of Colorado Denver Anschultz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Community Health Network

Recruiting

Indianapolis, Indiana, United States, 46256

Start Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.