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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06663319
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
May 2026
Primary completion
Feb 25, 2028
Completion
Jul 19, 2028

Study Design

Enrollment
220 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Experimental: Part 2 (Dose Expansion): Arm E
    Participants with metastatic gastric adenocarcinoma (mGAC) will receive JNJ-89402638 at the RP2D determined in Part 1.

Primary Outcome Measure

Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity [ Time Frame: From Baseline up to approximately 24 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Colorado Denver Anschultz Medical CampusAuroraColorado80045-
Florida Cancer SpecialistsSarasotaFlorida34232-
Community Health NetworkIndianapolisIndiana46256-
Start MidwestGrand RapidsMichigan49546-
Swedish Cancer InstituteSeattleWashington98104-

Find similar trials in Aurora, CO

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Colorado Denver Anschultz Medical Campus· Aurora, COFlorida Cancer Specialists· Sarasota, FLCommunity Health Network· Indianapolis, INStart Midwest· Grand Rapids, MISwedish Cancer Institute· Seattle, WA

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