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Testing DB-1305/BNT325 for advanced 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

PHASE1; PHASE2 · DualityBio Inc. · NCT05438329

This study is testing a new treatment called DB-1305/BNT325 to see if it is safe and effective for adults with advanced solid tumors that haven't responded to other therapies.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment1123 (estimated)
Ages18 Years and up
SexAll
SponsorDualityBio Inc. (industry)
Locations30 sites (Cerritos, California and 29 other locations)
Trial IDNCT05438329 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open-label, first-in-human trial evaluating the safety and tolerability of DB-1305/BNT325 in patients with advanced solid tumors. The study consists of two parts: an initial dose-escalation phase to determine the maximum tolerated dose (MTD) using a '3+3' design, followed by a dose expansion phase to confirm safety and explore efficacy at the MTD. Participants will include adults with unresectable, recurrent, or metastatic solid tumors who have not responded to standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed unresectable advanced or metastatic solid tumors that have progressed after standard treatments.

Not a fit: Patients with resectable tumors or those who have not progressed after standard systemic treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that have limited or no effective therapies available.

How similar studies have performed: Other studies have shown promise with similar approaches in treating advanced solid tumors, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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 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.

Where this trial is running

Cerritos, California and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Advanced Solid Tumor

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.