Esophageal Cancer Clinical Trial
Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
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).
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
Cohorts 1E, 1F, 1G, and 2A
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.
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.
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There are 20 Locations for this study
Stanford California, 94305, United States
Lafayette Colorado, 80026, United States
Tampa Florida, 33612, United States
Albuquerque New Mexico, 87131, United States More Info
Chuo-ku Other, 104-0, Japan More Info
Kashiwa-shi Other, 277-8, Japan More Info
Kawasaki-shi Other, 21685, Japan More Info
Koto-ku Other, 135-8, Japan More Info
Nagoya-shi Other, 464-8, Japan More Info
Osaka Other, 541-8, Japan More Info
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