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Recruiting NCT06663319

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

Phase I Interventional Colorectal Neoplasms Gastrointestinal Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JNJ-89402638, Bevacizumab, FOLFOX, FOLFIRI.
Who it may be relevant to
Registry conditions: Colorectal Neoplasms, Gastrointestinal Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, South Korea, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug JNJ-89402638
    JNJ-89402638 will be administered.
  • Drug Bevacizumab
    Bevacizumab or biosimilar will be administered.
  • Drug FOLFOX
    Chemotherapy agent FOLFOX will be administered.
  • Drug FOLFIRI
    Chemotherapy agent FOLFIRI will be administered.

Primary outcome measures

  • 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]
Secondary outcome measures (10)
  • Part 1 and Part 2: Serum Concentration for JNJ-89402638 [Time frame: Up to approximately 24 months]
  • Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638 [Time frame: Up to approximately 24 months]
  • Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638 [Time frame: Up to approximately 24 months]
  • Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638 [Time frame: Up to approximately 24 months]
  • Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638 [Time frame: Up to approximately 24 months]
  • Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-89402638 Antibodies [Time frame: Up to approximately 24 months]
  • Part 1 and Part 2: Overall Response (OR) [Time frame: Up to approximately 24 months]
  • Part 1 and Part 2: Complete Response (CR) [Time frame: Up to approximately 24 months]
  • Part 1 and Part 2: Time to Response (TTR) [Time frame: Up to approximately 24 months]
  • Part 1 and Part 2: Duration of Response (DOR) [Time frame: Up to approximately 24 months]

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 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
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • University of Colorado Denver Anschultz Medical Campus — Aurora
  • Florida Cancer Specialists — Sarasota
  • Community Health Network — Indianapolis
  • Start Midwest — Grand Rapids
  • Swedish Cancer Institute — Seattle
Spain · 4 centers
  • Hosp Univ Vall D Hebron — Barcelona
  • Hosp Univ Fund Jimenez Diaz — Madrid
  • Hosp. Univ. 12 de Octubre — Madrid
  • Hosp Univ Hm Sanchinarro — Madrid
South Korea · 2 centers
  • Severance Hospital Yonsei University Health System — Seoul
  • Asan Medical Center — Seoul

Identifiers

NCT: NCT06663319 · 89402638GIC1001 · 2024-516526-66-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗