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RECRUITING Phase 3

A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

NCT05253651 · View on ClinicalTrials.gov ↗

Study Summary

This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either: * mFOLFOX6 alone, * mFOLFOX6 with bevacizumab, or * mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.

Conditions Studied

Interventions

  • DRUG cetuximab
  • DRUG bevacizumab
  • DRUG tucatinib
  • DRUG trastuzumab
  • DRUG oxaliplatin

Study Locations (20)

California

  • Los Angeles Cancer Network - Anaheim — Anaheim
  • Kaiser Permanente Anaheim Kraemer Medical Offices — Anaheim
  • Kaiser Permanente Baldwin Park Medical Center — Baldwin Park
  • Kaiser Permanente Bellflower Medical Offices — Bellflower
  • Kaiser Permanente Fontana Medical Center — Fontana
  • Los Angeles Cancer Network - Fountain Vally — Fountain Valley
  • Los Angeles Hematology Oncology Medical Group — Glendale
  • Los Angeles Hematology Oncology Medical Group — Glendale
  • Kaiser Permanente South Bay Medical center — Harbor City
  • Kaiser Permanente Alton/Sand Canyon Medical Offices — Irvine
  • Los Angeles Hematology Oncology Medical Group — Los Angeles
  • USC Norris Koreatown - Medical Oncology — Los Angeles
  • Kaiser Permanente Los Angeles Medical Offices — Los Angeles
  • Keck Hospital of USC — Los Angeles
  • Los Angeles General Medical Center — Los Angeles
  • University of Southern California — Los Angeles

Arizona

  • Palo Verde Hematology Oncology — Glendale
  • Mayo Clinic Building - Phoenix — Phoenix
  • Mayo Clinic Hospital — Phoenix
  • Mayo Clinic — Scottsdale

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2022-10-24
Est. Completion 2029-07-27
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05253651

The ClinicalTrials.gov registry entry for NCT05253651 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Colorectal Neoplasms appearing as the primary indexed condition, and to 5 interventions — of which cetuximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05253651 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05253651 about?

NCT05253651 is a clinical study titled "A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer". This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything...

What is the current status of trial NCT05253651?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2022-10-24. Estimated completion is 2029-07-27.

What conditions does trial NCT05253651 study?

This clinical trial studies the following conditions: Colorectal Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05253651?

The interventions under investigation include: cetuximab (DRUG), bevacizumab (DRUG), tucatinib (DRUG), trastuzumab (DRUG), oxaliplatin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05253651?

This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05253651 being conducted?

This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial