Open Actively Recruiting

First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors


Brief Summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1305/BNT325 in subjects with advanced solid tumors.

Primary Purpose
Study Type
Phase 1/Phase 2


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

Inclusion Criteria:

  • Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
  • Histologically or cytologically confirmed unresectable advanced/ metastatic solid tumors who have relapsed or progressed on or after standard systemic treatments or for which no standard treatment is available.
  • At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria.
  • Has a life expectancy of ≥ 3 months.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
  • Has Left Ventricular Ejection Fraction (LVEF) ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
  • Has adequate organ functions within 7 days prior to Day 1 of Cycle 1.
  • Has adequate treatment washout period prior to Day 1 of Cycle 1.
  • Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of Trop-2 level and other biomarkers if not contraindicated.
  • Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.

Exclusion Criteria:

  • Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
  • Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
  • Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to > 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.
  • Has a medical history of non-infectious Interstitial Lung Diseases (ILD)/pneumonitis or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Has a lung-specific intercurrent clinically significant illness.
  • Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.
  • Subjects have human immunodeficiency virus (HIV) infection with acquired immune deficiency syndrome (AIDS) defining illness are not eligible for enrollment; However, subjects have had HIV infection with a cluster of differentiation 4 (CD4)+ T cell count > 350 cells/µL and no history of an AIDS-defining illness are eligible for entry.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Join this Trial

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Study Stats
Protocol No.
Breast Cancer
Cervical Cancer
Colorectal Cancer
Esophageal Cancer
Head and Neck Cancer
Lung Cancer
Other Cancer
Ovarian Cancer
Pancreatic Cancer
Stomach Cancer
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
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