Clareo Health | Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Seagen, a wholly owned subsidiary of Pfizer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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)
