Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients

This is Phase 1 dose finding trial with potential dose expansion to evaluate the safety, toxicity, recommended phase 2 dose (RP2D), and maximum tolerated dose (MTD) of Neratinib plus TDxD using a standard 3+3 dose escalation design in patients with metastatic or unresectable gastro-esophageal cancer that are HER2-overexpressing (IHC 3+ or IHC2+/ISH+) and any other gastrointestinal cancer with HER2 expression with IHC3+. Patients must have progressed or been intolerant of at least one prior line of chemotherapy + HER2 directed therapy.

Trial Details

NCT ID
NCT05274048
Phase
PHASE1
Sponsor
Fox Chase Cancer Center
Status
RECRUITING
Cancer Type
Gastric Cancer
Interventions
  • Neratinib Pill
  • Fam-Trastuzumab Deruxtecan-Nxki (TDxD)
Locations (sample)
  • Palo Alto, California, United States|37.44188,-122.14302
  • Buffalo, New York, United States|42.88645,-78.87837
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility Criteria

  • Patients must have been diagnosed with histologically or cytologically confirmed gastrointestinal cancer (esophagus, stomach, colon, biliary, pancr…
  • Patients must have evaluable or measurable disease by RECIST 1.1 criteria
  • 4.1.3 Patients' tumors must have HER2-overexpressing:
  • (IHC 3+ or IHC2+/ISH+) advanced gastroesophageal cancer (including gastroesophageal junction adenocarcinoma).

For full eligibility, visit ClinicalTrials.gov.

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