Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

The dose escalation phase of this trial identifies the safety, side effects and best dose of ceralasertib (AZD6738) when given in combination with trastuzumab deruxtecan (DS-8201a) in treating patients with solid tumors that have a change (mutation) in the HER2 gene or protein and have spread to other places in the body (advanced). The dose expansion phase (phase Ib) of this trial compares how colorectal and gastroesophageal cancers with HER2 mutation respond to treatment with a combination of ceralasertib and trastuzumab deruxtecan versus trastuzumab deruxtecan alone. Ceralasertib may stop th

Trial Details

NCT ID
NCT04704661
Phase
PHASE1
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Ceralasertib
  • Computed Tomography
  • Echocardiography Test
  • Multigated Acquisition Scan
Locations (sample)
  • Irvine, California, United States|33.66946,-117.82311
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311
  • Sacramento, California, United States|38.58157,-121.4944

Key Eligibility Criteria

  • DOSE-ESCALATION PHASE: Must have histologically confirmed advanced solid tumor including but not restricted to breast cancer, gastric or gastroesop…
  • DOSE-EXPANSION PHASE: Must have histologically confirmed advanced/metastatic gastroesophageal cancer (cohort A) or colorectal cancer (cohort B)
  • DOSE-EXPANSION PHASE: Patients must have a biopsiable lesion and provide consent for on treatment biopsy
  • Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of AZD6738 in combination with DS-8201a in patients \<…

For full eligibility, visit ClinicalTrials.gov.

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