Clinical Trials in the USA / NCT05438329
Active, not recruiting
Phase 1/2
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
NCT05438329 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Advanced Solid Tumor
Investigational drug(s) / intervention(s)
DB-1305/BNT325: Administered Injection of Vein (I.V.)
Pembrolizumab: Administered I.V.
BNT327: Administered I.V.
Study 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
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.
Primary outcome measure(s)
- Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. — up to 28 days after Cycle 1 Day 1
Percentage of participants in Part 1 with DLTs - Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0. — Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Percentage of participants with TEAEs in Part 1 graded according to NCI CTCAE v5.0 - Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0. — Up 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0 - Maximum Tolerated Dose (MTD) of DB-1305/BNT325 — At the end of Cycle 1 (each cycle is up to 21 days)
MTD on the data collected during Part 1 - Phase 1: RP2D of DB-1305/BNT325 — From first study treatment administration until the initiation of Phase 2a, approximately up to 12 months.
RP2D of DB-1305/BNT325 based on the data collected during Part 1 - Phase 2a: Percentage of Participants with TEAEs as assessed by CTCAE v5.0. — Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Percentage of participants with TEAEs in Part 2 graded according to NCI CTCAE v5.0 (secondary outcome measure in cohort 3) - Phase 2a: Percentage participants with SAEs as assessed by CTCAE v5.0. — Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0 (secondary outcome measure in cohort 3) - Phase 2a: Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. — Up to disease progression or death or before starting new anticancer treatment or withdrawal from the trial, whichever comes first, approximately up to 12 months.
The percentage of subjects who had a best response rating of CR and PR
Trial sites (93)
| Facility | City | Region | Status |
|---|---|---|---|
| Site 139 | Bullhead City | Arizona | |
| Site 103 | Cerritos | California | |
| Site 136 | La Jolla | California | |
| Site 127 | Los Angeles | California | |
| Site 133 | Los Angeles | California | |
| Site 108 | Los Angeles | California | |
| Site 131 | Washington D.C. | District of Columbia | |
| Site 122 | Coral Springs | Florida | |
| Site 142 | Hialeah | Florida | |
| Site 114 | Margate | Florida | |
| Site 120 | Miami | Florida | |
| Site 126 | Ocala | Florida | |
| Site 140 | Orange City | Florida | |
| Site 109 | Plantation | Florida | |
| Site 141 | St. Petersburg | Florida | |
| Site 117 | Tamarac | Florida | |
| Site 111 | Honolulu | Hawaii | |
| Site 134 | Chicago | Illinois | |
| Site 124 | Dearborn | Michigan | |
| Site 106 | Detroit | Michigan | |
| Site 125 | Royal Oak | Michigan | |
| Site 129 | Las Vegas | Nevada | |
| Site 160 | Mineola | New York | |
| Site 116 | New York | New York | |
| Site 102 | New York | New York | |
| Site 130 | Westbury | New York | |
| Site 121 | Wilson | North Carolina | |
| Site 101 | Canton | Ohio | |
| Site 132 | Cincinnati | Ohio | |
| Site 118 | Oklahoma City | Oklahoma | |
| Site 123 | Philadelphia | Pennsylvania | |
| Site 112 | Pittsburgh | Pennsylvania | |
| Site 105 | Nashville | Tennessee | |
| Site 110 | Arlington | Texas | |
| Site 104 | Houston | Texas | |
| Site 115 | Houston | Texas | |
| Site 119 | Tyler | Texas | |
| Site 107 | Fairfax | Virginia | |
| Site 135 | Falls Church | Virginia | |
| Site 128 | Tacoma | Washington |
+ 53 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More DualityBio Inc. trials in the USA
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05438329 on ClinicalTrials.gov ↗ ← All trials in the USA