A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.

Trial Details

NCT ID
NCT05150691
Phase
PHASE1 / PHASE2
Sponsor
DualityBio Inc.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • DB-1303/BNT323
  • Pertuzumab Injection
  • Ritonavir
  • Itraconazole
Locations (sample)
  • Cerritos, California, United States|33.85835,-118.06479
  • Los Angeles, California, United States|34.05223,-118.24368
  • San Diego, California, United States|32.71571,-117.16472
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Coral Springs, Florida, United States|26.27119,-80.2706

Key Eligibility Criteria

  • Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, …
  • At least 1 measurable lesion (per RECIST 1.1)
  • Provide signed informed consent
  • ECOG performance status (PS) of 0-1.

For full eligibility, visit ClinicalTrials.gov.

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