Trial Search Results

Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy for HER2+ Gastrointestinal Cancers

This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (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).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Seagen Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: tucatinib
  • Drug: trastuzumab
  • Drug: oxaliplatin
  • Drug: leucovorin
  • Drug: fluorouracil
  • Drug: capecitabine

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

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

      - CRC

      - Gastric adenocarcinoma

      - GEJ adenocarcinoma

      - Esophageal adenocarcinoma

      - Cholangiocarcinoma

      - Gallbladder carcinoma

   - Participants must be candidates to receive an oxaliplatin-based regimen as part of
   their standard-of-care treatment.

   - Participants in phase 1b cohorts or in Cohort 2B can be receiving an oxaliplatin-based
   regimen

      - For phase 1b cohorts utilizing FOLFOX: up to 2 cycles of FOLFOX (≤85 mg/m2
      oxaliplatin per 2-week cycle) may have been received prior to Cycle 1 Day 1 of
      study treatment

      - For phase 1b cohorts utilizing CAPOX: up to 2 cycles of FOLFOX (≤85 mg/m2
      oxaliplatin per 2-week cycle) or one cycle of CAPOX (≤130 mg/m2 oxaliplatin per
      3-week cycle) may have been received prior to Cycle 1 Day 1 of study treatment.

      - For all phase 1b cohorts: if subject has received oxaliplatin in prior cycles at
      higher doses than those listed above, there must be a minimum of 28 days off
      treatment prior to Cycle 1 Day 1 of treatment in this study.

      - For Cohort 2B prior to the first dose of study treatment:

         - Subjects may have received up to 1 cycle of FOLFOX (≤85 mg/m2 oxaliplatin
         per 2-week cycle) prior to Cycle 1 Day 1 but may not have received prior
         oxaliplatin for metastatic disease

         - Oxaliplatin received in an adjuvant setting is permitted if >6 months prior
         to Cycle 1 Day 1

         - At least 21 days must have elapsed from prior systemic anticancer therapy
         (including hormonal and biologic therapy but excluding 1 cycle of FOLFOX),
         non-central nervous system radiation, and treatment with other experimental
         agents

   - HER2+ disease, as determined by laboratory testing based on one of the following:

      - For CRC, cholangiocarcinoma, and gallbladder carcinoma:

         - HER2 amplification or overexpression from fresh or archival tumor tissue
         utilizing one of the following Clinical Laboratory Improvement Amendments
         (CLIA) certified or International Organization for Standardization (ISO)
         tests:

            - HER2 overexpression (3+ immunohistochemistry [IHC])

            - HER2 (ERBB2) amplification by in situ hybridization assay (fluorescence
            in situ hybridization [FISH] or chromogenic in situ hybridization
            signal ratio ≥2.0 or gene copy number >6)

            - HER2 (ERBB2) amplification by next generation sequencing (NGS) assay

         - HER2 amplification in a CLIA certified blood-based NGS assay

      - Gastric, GEJ, and esophageal adenocarcinomas must use the following criteria:

         - HER2+ overexpression (IHC3+) by an FDA approved assay, from a newly obtained
         biopsy or surgical specimen, evaluated following the package insert's
         interpretational manual for gastric adenocarcinoma. IHC2+ is eligible if the
         tumor is HER2 amplified by an FDA approved in situ hybridization assay

   - 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 oxaliplatin, fluoropyrimidines, leucovorin,
   trastuzumab, or compounds chemically or biologically similar to tucatinib, except for
   Grade 1 or 2 infusion related reactions to oxaliplatin or trastuzumab that were
   successfully managed, or known allergy to any of the excipients in the study drugs

   - Treatment with oxaliplatin dose in excess of the limitations specified in the
   inclusion criteria

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Smruti Rahalkar
650-498-5186
Recruiting