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A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers
NCT06663319 · Janssen Research & Development, LLC
In plain English
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Official title
A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies
About this study
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.
Eligibility criteria
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 design
Enrollment target: 220 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-10-15
Estimated completion: 2028-07-19
Last updated: 2026-04-13
Interventions
Drug: JNJ-89402638Drug: BevacizumabDrug: FOLFOXDrug: FOLFIRI
Primary outcomes
- • Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity (From Baseline up to approximately 24 months)
- • Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) (From Baseline up to 28 days)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (10)
University of Colorado Denver Anschultz Medical CampusRecruiting
Aurora, Colorado, United States
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
Community Health NetworkRecruiting
Indianapolis, Indiana, United States
Start MidwestRecruiting
Grand Rapids, Michigan, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
Asan Medical CenterRecruiting
Seoul, South Korea
Hosp Univ Vall D HebronRecruiting
Barcelona, Spain
Hosp Univ Fund Jimenez DiazRecruiting
Madrid, Spain
Hosp. Univ. 12 de OctubreRecruiting
Madrid, Spain
Hosp Univ Hm SanchinarroRecruiting
Madrid, Spain