Esophageal Cancer Clinical Trial

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

Summary

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants must have an unresectable or metastatic solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below:

Cohorts 1A, 1B, 1C, and 1D

CRC
Gastric adenocarcinoma
GEJ adenocarcinoma
Esophageal adenocarcinoma
Cholangiocarcinoma
Gallbladder carcinoma

Cohorts 1E, 1F, 1G, and 2A

Gastric adenocarcinoma
GEJ adenocarcinoma
Esophageal adenocarcinoma

Cohort 2B

CRC
Participants must be candidates to receive an oxaliplatin-based regimen as part of their standard-of-care treatment for all cohorts, except Cohort 1G.
HER2+ disease, as determined by historic or local laboratory testing
Phase 1b cohorts: measurable or non-measurable disease according to RECIST v1.1 as determined by the investigator
Phase 2 cohorts: measurable disease according to RECIST v1.1 as determined by the investigator
Eastern Cooperative Oncology Group Performance Status score of 0 or 1.

Exclusion Criteria:

History of known hypersensitivity to planned study treatment
Known to be positive for Hepatitis B or C
For Cohorts 2A and 2B: prior anti-HER2 therapies
For Cohorts 1E, 1F, 1G, 2A: Prior therapy with an anti-PD-1, anti-immunotherapy-drugs-are-boosting-survival/" >PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE)

There are additional inclusion criteria. The study center will determine if criteria for participations are met.

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT04430738

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 20 Locations for this study

See Locations Near You

Mayo Clinic Arizona
Phoenix Arizona, 85054, United States More Info
Mayo Clinic Arizona Clinical Trials Referral Office Inbox
Contact
855-776-0015
Lundon Bywater
Contact
480-574-2425
[email protected]
Tanios Bekaii-Saab
Principal Investigator
Stanford University School of Medicine
Stanford California, 94305, United States
University of Colorado Hospital / University of Colorado
Aurora Colorado, 80045, United States More Info
Matthew Lee
Contact
720-848-0300
[email protected]
Sunnie Kim
Principal Investigator
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
Lafayette Colorado, 80026, United States
Johns Hopkins Medical Center
Washington District of Columbia, 20016, United States More Info
Carol Goldener
Contact
220-660-6500
[email protected]
Kai Hajos
Contact
202-660-6791
[email protected]
Michael Pishvaian
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States More Info
Alex (Ryan) El-Naggar
Contact
773-702-7763
[email protected]
Chih-Yi Liao
Principal Investigator
Mayo Clinic Rochester
Rochester Minnesota, 55903, United States More Info
Suzanne Greiner
Contact
[email protected]
Joleen Hubbard
Principal Investigator
Washington University in St Louis
Saint Louis Missouri, 63110, United States More Info
Jordan Wynn
Contact
314-273-4913
[email protected]
Patrick Grierson
Contact
(314) 362-5740
[email protected]
Patrick Grierson
Principal Investigator
University of New Mexico Cancer Center
Albuquerque New Mexico, 87131, United States More Info
Ursa Brown-Glaberman
Principal Investigator
Duke University Medical Center
Durham North Carolina, 27710, United States More Info
Sabina Wlazlo Cascalherio
Contact
919-613-4812
[email protected]
John Strickler
Principal Investigator
Gabrail Cancer Center Research, LLC
Canton Ohio, 44718, United States More Info
Carrie Smith
Contact
330-492-3345
[email protected]
Nashat Gabrail
Principal Investigator
Cleveland Clinic, The
Cleveland Ohio, 44195, United States More Info
Suneel Kamath
Contact
216-445-9451
[email protected]
Suneel Kamath
Principal Investigator
Seattle Cancer Care Alliance / University of Washington
Seattle Washington, 98109, United States More Info
Madilyn Heit
Contact
206-606-6387
[email protected]
David Zhen
Principal Investigator
National Cancer Center Hospital
Chuo-ku Other, 104-0, Japan More Info
Satoru Iwasa
Principal Investigator
National Cancer Center Hospital East
Kashiwa-shi Other, 277-8, Japan More Info
Kohei Shitara
Principal Investigator
St. Marianna University School of Medicine
Kawasaki-shi Other, 21685, Japan More Info
Yu Sunakawa
Principal Investigator
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku Other, 135-8, Japan More Info
Kensei Yamaguchi
Principal Investigator
Aichi Cancer Center
Nagoya-shi Other, 464-8, Japan More Info
Kei Muro
Principal Investigator
Osaka International Cancer Institute
Osaka Other, 541-8, Japan More Info
Naotoshi Sugimoto
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT04430738

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

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