Testing JNJ-89402638 for advanced colorectal cancer

A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies

This study is testing a new drug called JNJ-89402638 to see if it is safe and what the right dose is for people with advanced colorectal cancer that hasn't responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Janssen Research & Development, LLC (Industry-sponsored)
• Drugs / interventions: bevacizumab, prednisone, chemotherapy
• Locations: 11 sites (Aurora, Colorado and 10 other locations)
• Trial ID: NCT06663319 on ClinicalTrials.gov

What this trial studies

This study aims to identify the recommended phase 2 doses of JNJ-89402638 and evaluate its safety in patients with unresectable metastatic colorectal cancer. Participants must have a confirmed diagnosis of colorectal adenocarcinoma that has progressed after at least two prior treatments. The study will assess the drug's effects on measurable disease using established response criteria. The research is designed to provide insights into the dosing and safety profile of this new treatment option.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable metastatic colorectal cancer who have experienced disease progression after two or more standard therapies.

Not a fit: Patients with active brain metastases or significant unresolved toxicity from previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients with advanced colorectal cancer who have limited alternatives.

How similar studies have performed: Other studies have explored similar therapeutic approaches for metastatic colorectal cancer, but the specific drug JNJ-89402638 is being evaluated for the first time in this context.

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

Where this trial is running

Aurora, Colorado and 10 other locations

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

Study contacts

• Study coordinator: Study Contact

Conditions Colorectal Neoplasms; Gastrointestinal Neoplasms