A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

NCT06663319 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 89402638GIC10012024-516526-66-00
• Study Type: interventional
• Target: 220
• Locations: 3 countries
• Sites: 11

Brief Summary

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.

Conditions

Colorectal Neoplasms; Gastrointestinal Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Part 1 and Part 2: Serum Concentration for JNJ-89402638

  Up to approximately 24 months

• Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638

  Up to approximately 24 months

• Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638

  Up to approximately 24 months

• Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638

  Up to approximately 24 months

• Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638

  Up to approximately 24 months

Study Arms (6)

Part 1 (Dose Expansion)

EXPERIMENTAL

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

Part 2 (Dose Expansion): Arm A

EXPERIMENTAL

Participants with mCRC will receive JNJ-89402638 at the RP2D(s) determined in Part 1 as a monotherapy.

Drug: JNJ-89402638

Part 2 (Dose Expansion): Arm B

EXPERIMENTAL

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

Part 2 (Dose Expansion): Arm C

EXPERIMENTAL

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

Part 2 (Dose Expansion): Arm D

EXPERIMENTAL

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

Part 2 (Dose Expansion): Arm E

EXPERIMENTAL

Participants with metastatic gastric adenocarcinoma (mGAC) will receive JNJ-89402638 at the RP2D determined in Part 1.

Drug: JNJ-89402638

Interventions

JNJ-89402638 DRUG

JNJ-89402638 will be administered.

Part 1 (Dose Expansion); Part 2 (Dose Expansion): Arm A; Part 2 (Dose Expansion): Arm B; Part 2 (Dose Expansion): Arm C; Part 2 (Dose Expansion): Arm D; Part 2 (Dose Expansion): Arm E

Bevacizumab DRUG

Bevacizumab or biosimilar will be administered.

Part 2 (Dose Expansion): Arm B; Part 2 (Dose Expansion): Arm C; Part 2 (Dose Expansion): Arm D

FOLFIRI DRUG

Chemotherapy agent FOLFIRI will be administered.

Part 2 (Dose Expansion): Arm D

FOLFOX DRUG

Chemotherapy agent FOLFOX will be administered.

Part 2 (Dose Expansion): Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Part 1: Must have either measurable or evaluable disease
• 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

You may not qualify if:

• Active (new or progressive) brain metastases, leptomeningeal disease, or untreated spinal cord compression
• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (11)

University of Colorado Denver Anschultz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Community Health Network

Indianapolis, Indiana, 46256, United States

RECRUITING

Start Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

RECRUITING

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hosp Univ Hm Sanchinarro

Madrid, 28050, Spain

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Gastrointestinal Neoplasms

Interventions

Bevacizumab; Folfox protocol; IFL protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 29, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): February 25, 2028
• Study Completion (Estimated): July 19, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (5); ES (4); KR (2)