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DB-1305/BNT325 for Advanced Solid Tumors

This study is testing a new treatment, DB-1305/BNT325, sometimes combined with Pembrolizumab or BNT327, for people with advanced or metastatic (spread to other parts of the body) solid tumors that have not responded to standard treatments. The main goals are to find a safe dose and understand any side effects of DB-1305/BNT325. Researchers will also look at how well the treatment works. You might be able to join if you are an adult (18 or older) with a confirmed advanced solid tumor that has progressed after other treatments. The study is currently recruiting participants.

Study design
This is a Phase 1/2a, open-label study, meaning both you and the study team will know which treatment you are receiving. It plans to enroll up to 1123 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for side effects for up to 30 days after your last study treatment or before starting new anticancer treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05438329

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
DualityBio Inc.
~1,123 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:DB-1305/BNT325PembrolizumabBNT327

At a glance

Recruiting sites
0 of 93 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over up to 28 days after Cycle 1 Day 1
+7 more outcomes measured

Conditions

Advanced Solid Tumor

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Solid Neoplasm

NCT05438329

Where you'd take part

This study runs at 93 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Site 101

    Canton, Ohiono site contact published

  • Site 102

    New York, New Yorkno site contact published

  • Site 103

    Cerritos, Californiano site contact published

  • Site 104

    Houston, Texasno site contact published

  • Site 105

    Nashville, Tennesseeno site contact published

  • Site 106

    Detroit, Michiganno site contact published

  • Site 107

    Fairfax, Virginiano site contact published

  • Site 108

    Los Angeles, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Lily Hu · STUDY_DIRECTOR · DualityBio Inc.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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/BNT325At 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/BNT325From 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