RecruitingPhase 1Phase 2NCT05438329
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1305 in Subjects With Advanced/Metastatic Solid Tumors
Sponsor
DualityBio Inc.
Enrollment
1,123 participants
Start Date
Jul 19, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- 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 Criteria7
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGDB-1305/BNT325
Administered Injection of Vein (I.V.)
COMBINATION_PRODUCTPembrolizumab
Administered I.V.
DRUGBNT327
Administered I.V.
Locations(30)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05438329
Related Trials
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies
NCT0721383011 locations
A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours
NCT0683300813 locations
Study in Advanced Solid Tumor Patients
NCT0730094311 locations
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
NCT0614703715 locations
A Study of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Solid Tumors
NCT072987721 location