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

The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) of 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 Overview

• Status: Recruiting
• Conditions: Gastrointestinal Neoplasms; Colorectal Neoplasms
• Intervention / Treatment: Drug: JNJ-89402638; Drug: FOLFOX; Drug: FOLFIRI; Drug: Bevacizumab

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• South Korea
  • Seoul, South Korea, 05505
    • Recruiting
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Recruiting
    • Severance Hospital Yonsei University Health System
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hosp Univ Vall D Hebron
  • Madrid, Spain, 28041
    • Recruiting
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28040
    • Recruiting
    • Hosp Univ Fund Jimenez Diaz
  • Madrid, Spain, 28050
    • Recruiting
    • Hosp Univ Hm Sanchinarro
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Denver Anschultz Medical Campus
  • Florida
    • Sarasota, Florida, United States, 34232
      • Recruiting
      • Florida Cancer Specialists
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Recruiting
      • Community Health Network
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • Start Midwest
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Swedish Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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

  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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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) for JNJ-89402638 monotherapy have been identified.	Drug: JNJ-89402638; JNJ-89402638 will be administered.
Experimental: Part 2 (Dose Expansion): Arm A; Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 as a monotherapy.	Drug: JNJ-89402638; JNJ-89402638 will be administered.
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.	Drug: JNJ-89402638; JNJ-89402638 will be administered.; Drug: Bevacizumab; Bevacizumab or biosimilar will be administered.
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.	Drug: JNJ-89402638; JNJ-89402638 will be administered.; Drug: FOLFOX; Chemotherapy agent FOLFOX will be administered.; Drug: Bevacizumab; Bevacizumab or biosimilar will be administered.
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.	Drug: JNJ-89402638; JNJ-89402638 will be administered.; Drug: FOLFIRI; Chemotherapy agent FOLFIRI will be administered.; Drug: Bevacizumab; Bevacizumab or biosimilar will be administered.
Experimental: Part 2 (Dose Expansion): Arm E; Participants with metastatic gastric adenocarcinoma (mGAC) will receive JNJ-89402638 at the RP2D determined in Part 1.	Drug: JNJ-89402638; JNJ-89402638 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From Baseline up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and Part 2: Serum Concentration for JNJ-89402638	Serum Concentration for JNJ-89402638 will be reported.	Up to approximately 24 months
Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638	Cmax of JNJ-89402638 will be reported.	Up to approximately 24 months
Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638	Cmin of JNJ-89402638 will be reported.	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.	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.	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.	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.	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.	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.	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	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): February 25, 2028
• Study Completion (Estimated): July 19, 2028

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Gastrointestinal Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab; Folfox protocol; IFL protocol
• Other Study ID Numbers: 89402638GIC1001 (Janssen Research & Development, LLC); 2024-516526-66-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No