๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-02-05

Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers (NCT04430738)

A Phase 1b/2 Dose Escalation and Expansion Study of Tucatinib in Combination With Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Seagen, a wholly owned subsidiary of Pfizer

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. It will also look at whether tucatinib works with these drugs to treat certain types of cancer. The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic Hospital โ€” Phoenix, Arizona

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (27 Sites)

Showing the first 25 of 27 sites.

  • Mayo Clinic Hospital โ€” Phoenix, Arizona
  • Mayo Clinic โ€” Scottsdale, Arizona
  • University of Colorado Denver CTO(CTRC) โ€” Aurora, Colorado
  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) โ€” Aurora, Colorado
  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) โ€” Aurora, Colorado
  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) โ€” Aurora, Colorado
  • PCM Trials โ€” Denver, Colorado
  • Sibley Memorial Hospital โ€” Washington D.C., District of Columbia
  • Siteman Cancer Center - St Peters โ€” City of Saint Peters, Missouri
  • Siteman Cancer Center - West County โ€” Creve Coeur, Missouri
  • Siteman Cancer Center - North County โ€” Florissant, Missouri
  • Siteman Cancer Center โ€” St Louis, Missouri
  • Barnes-Jewish Hospital โ€” St Louis, Missouri
  • Washington University School of Medicine โ€” St Louis, Missouri
  • Siteman Cancer Center - South County โ€” St Louis, Missouri
  • University of New Mexico Comprehensive Cancer Center โ€” Albuquerque, New Mexico
  • Duke University Medical Center, Duke Cancer Center โ€” Durham, North Carolina
  • Duke University Medical Center โ€” Durham, North Carolina
  • Cleveland Clinic โ€” Cleveland, Ohio
  • Fred Hutchinson Cancer Center โ€” Seattle, Washington
  • University of Washington Medical Center โ€” Seattle, Washington
  • Aichi Cancer Center Hospital โ€” Nagoya, Aichi-ken
  • National Cancer Center Hospital East โ€” Kashiwa-shi, Chiba
  • St. Marianna University Hospital โ€” Kawasaki, Kanagawa
  • Osaka International Cancer Institute โ€” Osaka, Osaka

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 664-4580

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—