A Study to Evaluate Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy for HER2+ Gastrointestinal Cancers


About this study

The purpose of this study is to determine the recommended dose of tucatinib when combined with trastuzumab and modified FOLFOX7 (mFOLFOX7) or CAPOX in subjects with human epidermal growth factor receptor 2 (HER2)+ gastrointestinal cancers.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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


- Gastric adenocarcinoma

- GEJ adenocarcinoma

- Esophageal adenocarcinoma

- Cholangiocarcinoma

- Gallbladder carcinoma

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

- Gastric adenocarcinoma

- GEJ adenocarcinoma

- Esophageal adenocarcinoma

- Cohort 2B


- 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

- 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-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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Tanios Bekaii-Saab, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions