Overview

First-in-human Study of DB-1303 for Advanced/Metastatic Solid Tumors

Status:
Not yet recruiting
Trial end date:
2025-06-30
Target enrollment:
0
Participant gender:
All
Summary
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1305 in subjects with advanced solid tumors.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
DualityBio Inc.
Criteria
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 response
evaluation criteria in solid tumors (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 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 no
contraindication.

- 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 interstitial lung diseases (e.g., non-infectious interstitial
pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or
current interstitial lung diseases or who are suspected to have these diseases by
imaging at screening.

- 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.