First-in-human Study of DB-1305/BNT325 for Advanced/Metas... | NCT05438329 | Trialant
NCT05438329
Sponsor
DualityBio Inc.
Status
Active, not recruiting
Last Update Posted
May 12, 2026Actual
Enrollment
1,123Estimated
Phase
Phase 1Phase 2
Conditions
Advanced Solid Tumor
Interventions
DB-1305/BNT325
Pembrolizumab
BNT327
Countries
United States
China
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT05438329
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
DB-1305-O-1001
Secondary IDs
Not provided
Brief Title
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
Official Title
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
Acronym
Not provided
Organization
DualityBio Inc.INDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 19, 2022Actual
Primary Completion Date
Aug 13, 2027Estimated
Completion Date
Sep 10, 2027Estimated
First Submitted Date
Jun 14, 2022
First Submission Date that Met QC Criteria
Jun 24, 2022
First Posted Date
Jun 29, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 8, 2026
Last Update Posted Date
May 12, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
DualityBio Inc.INDUSTRY
Collaborators
Name
Class
BioNTech SE
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed Description
This is a multicenter, open-label, multiple-dose, first in human (FIH) study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D); Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic malignant solid tumors.
Conditions Module
Conditions
Advanced Solid Tumor
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,123Estimated
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
DB-1305/BNT325 Dose Level 1
Experimental
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 1
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Level 2
Experimental
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 2
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Level 3
Experimental
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 3
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Level 4
Experimental
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 4
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Level 5
Experimental
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 5
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Level 6
Experimental
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 6
Interventions
Name
Type
Description
Arm Group Labels
Other Names
DB-1305/BNT325
Drug
Administered Injection of Vein (I.V.)
DB-1305/BNT325 Dose Expansion 1
DB-1305/BNT325 Dose Expansion 11
DB-1305/BNT325 Dose Expansion 12
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Percentage of participants in Part 1 with DLTs
up to 28 days after Cycle 1 Day 1
Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Percentage of participants with TEAEs in Part 1 graded according to NCI CTCAE v5.0
Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0
Up 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Maximum Tolerated Dose (MTD) of DB-1305/BNT325
MTD on the data collected during Part 1
At the end of Cycle 1 (each cycle is up to 21 days)
Phase 1: RP2D of DB-1305/BNT325
RP2D of DB-1305/BNT325 based on the data collected during Part 1
From first study treatment administration until the initiation of Phase 2a, approximately up to 12 months.
Phase 2a: Percentage of Participants with TEAEs as assessed by CTCAE v5.0.
Percentage of participants with TEAEs in Part 2 graded according to NCI CTCAE v5.0 (secondary outcome measure in cohort 3)
Secondary Outcomes
Measure
Description
Time Frame
Phase 1: ORR will be determined from tumor assessments by investigator per RECIST 1.1
Phase 1: ORR will be determined from tumor assessments by investigator per RECIST 1.1
with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: duration of response (DoR) will be determined from tumor assessments by investigator per RECIST 1.1
Other Outcomes
Not provided
Eligibility Module
Eligibility 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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Lily Hu
DualityBio Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Site 139
Bullhead City
Arizona
86442
United States
Site 103
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Level 7
Experimental
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 7
Drug: DB-1305/BNT325
DB-1305/BNT325 in combination with pembrolizumab
Experimental
Enrolled subjects will receive DB-1305/BNT325 in combination with pembrolizumab
Drug: DB-1305/BNT325
Combination Product: Pembrolizumab
DB-1305/BNT325 Dose Expansion 1
Experimental
subjects with Non-Small Cell Lung Cancer (NSCLC) with actionable genetic alterations (AGAs) who will receive DB-1305/BNT325 on either dose level 1 or dose level 2
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Expansion 2
Experimental
Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on either dose level 1 or dose level 2
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Expansion 3
Experimental
Enrolled subjects with OC who will receive DB-1305/BNT325 on either dose level 1 or dose level 2
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Expansion 4
Experimental
Enrolled subjects with BC who will receive DB-1305/BNT325 on a selected dose level (RP2D)
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Expansion 5
Experimental
Enrolled subjects with Triple-Negative Breast Cancer (TNBC) who have progressed on or after standard systemic treatments and without prior treatment of sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D)
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Expansion 6
Experimental
Enrolled subjects with TNBC with treatment failure on sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D)
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Expansion 7
Experimental
Enrolled subjects with EC who will receive DB-1305/BNT325 on a selected dose level (RP2D)
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Expansion 8
Experimental
Enrolled subjects with malignant mesothelioma will receive DB-1305/BNT325 on a selected dose level (RP2D)
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Expansion 9
Experimental
Enrolled subjects with Cervical Cancer (CC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)
Drug: DB-1305/BNT325
Experimental: DB-1305/BNT325 Dose Expansion 10
Experimental
Enrolled subjects with pancreatic cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Expansion 11
Experimental
Enrolled subjects with Castration-Resistant Prostate Cancer (CRPC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Expansion PB1
Experimental
Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with pembrolizumab
Drug: DB-1305/BNT325
Combination Product: Pembrolizumab
Experimental: DB-1305/BNT325 Dose Level 8
Experimental
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 8
Drug: DB-1305/BNT325
Experimental: DB-1305/BNT325 in combination with BNT327
Experimental
Enrolled subjects will receive DB-1305/BNT325 in combination with BNT327
Drug: DB-1305/BNT325
Drug: BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM1
Experimental
Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Drug: DB-1305/BNT325
Drug: BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM2
Experimental
Enrolled subjects with NSCLC with AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Drug: DB-1305/BNT325
Drug: BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM3
Experimental
Enrolled subjects with CC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Drug: DB-1305/BNT325
Drug: BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM4
Experimental
Enrolled subjects with OC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Drug: DB-1305/BNT325
Drug: BNT327
Experimental: DB-1305/BNT325 Dose Expansion PM5
Experimental
Enrolled subjects with TNBC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Drug: DB-1305/BNT325
Drug: BNT327
DB-1305/BNT325 Dose Expansion 12
Experimental
Enrolled subjects with head and neck cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Level 9
Experimental
Enrolled subjects will receive DB-1305/BNT325 at Dose Level 9
Drug: DB-1305/BNT325
DB-1305/BNT325 Dose Expansion PM6
Experimental
Enrolled subjects with NSCLC without AGA who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327
Drug: DB-1305/BNT325
Drug: BNT327
DB-1305/BNT325 Dose Expansion 2
DB-1305/BNT325 Dose Expansion 3
DB-1305/BNT325 Dose Expansion 4
DB-1305/BNT325 Dose Expansion 5
DB-1305/BNT325 Dose Expansion 6
DB-1305/BNT325 Dose Expansion 7
DB-1305/BNT325 Dose Expansion 8
DB-1305/BNT325 Dose Expansion 9
DB-1305/BNT325 Dose Expansion PB1
DB-1305/BNT325 Dose Expansion PM6
DB-1305/BNT325 Dose Level 1
DB-1305/BNT325 Dose Level 2
DB-1305/BNT325 Dose Level 3
DB-1305/BNT325 Dose Level 4
DB-1305/BNT325 Dose Level 5
DB-1305/BNT325 Dose Level 6
DB-1305/BNT325 Dose Level 7
DB-1305/BNT325 Dose Level 9
DB-1305/BNT325 in combination with pembrolizumab
Experimental: DB-1305/BNT325 Dose Expansion 10
Experimental: DB-1305/BNT325 Dose Expansion PM1
Experimental: DB-1305/BNT325 Dose Expansion PM2
Experimental: DB-1305/BNT325 Dose Expansion PM3
Experimental: DB-1305/BNT325 Dose Expansion PM4
Experimental: DB-1305/BNT325 Dose Expansion PM5
Experimental: DB-1305/BNT325 Dose Level 8
Experimental: DB-1305/BNT325 in combination with BNT327
DB-1305/BNT325 for Injection
Pembrolizumab
Combination Product
Administered I.V.
DB-1305/BNT325 Dose Expansion PB1
DB-1305/BNT325 in combination with pembrolizumab
BNT327
Drug
Administered I.V.
DB-1305/BNT325 Dose Expansion PM6
Experimental: DB-1305/BNT325 Dose Expansion PM1
Experimental: DB-1305/BNT325 Dose Expansion PM2
Experimental: DB-1305/BNT325 Dose Expansion PM3
Experimental: DB-1305/BNT325 Dose Expansion PM4
Experimental: DB-1305/BNT325 Dose Expansion PM5
Experimental: DB-1305/BNT325 in combination with BNT327
Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Phase 2a: Percentage participants with SAEs as assessed by CTCAE v5.0.
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0 (secondary outcome measure in cohort 3)
Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first.
Phase 2a: Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
The percentage of subjects who had a best response rating of CR and PR
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.
Phase 1 & Phase 2a: duration of response (DoR) will be determined from tumor assessments by investigator (by BICR in cohort 3 in Phase 2a) per RECIST 1.1
with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: disease-control rate (DCR)
Phase 1 & Phase 2a: disease-control rate (DCR)
with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: time to response (TTR)
Phase 1 & Phase 2a: time to response (TTR)
with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: progression free survival (PFS) will be determined from tumor assessments by investigator per RECIST 1.1
Phase 1 & Phase 2a: progression free survival (PFS) will be determined from tumor assessments by investigator (by BICR in cohort 3 in Phase 2a) per RECIST 1.1
with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: overall survival (OS)
Phase 1 & Phase 2a: overall survival (OS)
with 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: Pharmacokinetic parameters: (the area under the concentration-time curve from the time zero to the last quantifiable concentration [AUC0-last] of DB-1305/BNT325
Phase 1 & Phase 2a: Pharmacokinetic parameters: (the area under the concentration-time curve from the time zero to the last quantifiable concentration [AUC0-last] of DB-1305/BNT325
within 8 cycles (each cycle is up to 21 days)
Phase 1 & Phase 2a: Pharmacokinetic parameters: the area under the concentration-time curve from time 0 to tau [AUC0-tau] of DB-1305/BNT325
Phase 1 & Phase 2a: Pharmacokinetic parameters: the area under the concentration-time curve from time 0 to tau [AUC0-tau] of DB-1305/BNT325
Phase 1 & Phase 2a: anti-drug antibody (ADA) prevalence: the proportion of subjects who are ADA positive at any point in time (at baseline and post-baseline). ADA incidence: the proportion of subjects having treatment-emergent ADA.
Phase 1 & Phase 2a: anti-drug antibody (ADA) prevalence of DB-1305: the proportion of subjects who are ADA positive at any point in time (at baseline and post-baseline). ADA incidence of DB-1305: the proportion of subjects having treatment-emergent ADA.