A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastat... | NCT05150691 | Trialant
NCT05150691
Sponsor
DualityBio Inc.
Status
Recruiting
Last Update Posted
Jan 28, 2026Actual
Enrollment
796Estimated
Phase
Phase 1Phase 2
Conditions
HER2-positive Advanced Solid Tumor
Interventions
DB-1303/BNT323
Pertuzumab Injection
Ritonavir
Itraconazole
Countries
United States
Australia
China
Puerto Rico
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT05150691
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
DB-1303-O-1001
Secondary IDs
Not provided
Brief Title
A Phase 1/2a Study of DB-1303/BNT323 in 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-1303/BNT323 in Patients With Advanced/Metastatic Solid Tumors
Acronym
Not provided
Organization
DualityBio Inc.INDUSTRY
Status Module
Record Verification Date
Jan 2026
Overall Recruitment Status or Expanded Access Status
Recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 31, 2022Actual
Primary Completion Date
Apr 2026Estimated
Completion Date
Oct 2027Estimated
First Submitted Date
Nov 11, 2021
First Submission Date that Met QC Criteria
Nov 26, 2021
First Posted Date
Dec 9, 2021Actual
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
Jan 27, 2026
Last Update Posted Date
Jan 28, 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-1303/BNT323 in subjects with advanced solid tumors that express HER2.
Detailed Description
This is a multicenter, non-randomized (Except for Dose Expansion 1 and Dose Expansion 9 cohorts), open-label, multiple-dose, 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 MTD/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 HER2-expressing malignant solid tumors.
Conditions Module
Conditions
HER2-positive Advanced Solid Tumor
Keywords
HER2
HER2-positive
HER2-positive Breast Cancer
HER2-positive Gastric Cancer
HER2-positive Endometrial Cancer
HER2-positive Biliary Tract Cancer
HER2-positive Advanced Solid Tumor
HER2 low
HER2 high
metastatic cancer
HER2-positive GEJ
Uterine serous papillary carcinoma
USPC
recurrent cancer
carcinoma
neoplasms
breast neoplasms
gastrointestinal neoplasms
endometrial neoplasms
biliary tract neoplasms
Antineoplastic Agents, Biological
stomach cancer
bile duct cancer
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
796Estimated
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
DB-1303/BNT323 Dose Level 1
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 1 on Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 2
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 2 on Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 3
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 3 on Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 4
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 4 on Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 5
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 5 on Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
Interventions
Name
Type
Description
Arm Group Labels
Other Names
DB-1303/BNT323
Biological
Administered IV
DB-1303/BNT323 Dose Expansion 1
DB-1303/BNT323 Dose Expansion 10
DB-1303/BNT323 Dose Expansion 11
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.
Percentage of participants in Part 1 with DLTs
up to 21 days after C1D1
Phase 1: Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Adverse Event of Special Interest include those >/= G3 leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0, abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).
Up to Safety Follow-Up visit, approximately 35 days post-treatment
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 to follow-up period, approximately 1 year post-treatment
Phase 1: Maximum Tolerated Dose (MTD) of DB-1303
MTD on the data collected during Part 1
Up to Safety Follow-Up visit, approximately 35 days post-treatment
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1303
RP2D of DB-1303 based on the data collected during Part 1
Up to Safety Follow-Up visit, approximately 35 days post-treatment
Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0
Phase 2: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Adverse Event of Special Interest include those >/= G3 leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0, abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).
Secondary Outcomes
Measure
Description
Time Frame
Phase 1 & Phase 2: Pharmacokinetic-AUC
Area under the concentration-time curve from time 0 to infinity of DB-1303
Up to safety follow up visit, approx. 35 days post-treatment
Phase 1 & Phase 2: Pharmacokinetic-Cmax
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
At least 1 measurable lesion (per RECIST 1.1)
Provide signed informed consent
ECOG performance status (PS) of 0-1.
LVEF ≥ 50% by ECHO or MUGA
Adequate organ functions
Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.
Life expectancy of ≥ 3 months.
Additional Inclusion Criteria for Part 2 Expansion Group 9:
1. Has pathologically documented advanced/unresectable, recurrent, or metastatic EC (including UCS and USPC) and has progressed on or after at least 1 line of systemic treatment including platinum-based therapy and exposure to ICI but no more than prior 3 lines of therapy for advanced/unresectable, or metastatic disease. Note: endocrine therapy will not qualify as a systemic therapy line.
Exclusion Criteria:
History of symptomatic CHF (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
History of myocardial infarction or unstable angina within 6 months before Day 1.
Average QTcF > 450 ms in males and > 470 ms in females
History of clinically significant lung diseases
Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
HIV infection with AIDS defining illness or active viral hepatitis.
Clinically active brain metastases
Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline.
A known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
Part 2 (expansion) Only:Multiple primary malignancies within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.
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
Name
Role
Phone
Extension
Email
Britney Winterberger
Contact
+1-513-403-8568
britney.winterberger@tigermedgrp.com
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Helios Clinical Research
Active, not recruiting
Cerritos
California
90703
United States
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
MeSH Terms
Intervention Browse Module
MeSH Terms
Cholangiocarcinoma
liver cancer
liver neoplasms
NSCLC
Non-Small Cell Lung Cancer
NSCLC HER2 mutation
HER2 Low Breast Cancer
Randomized
Intervention Model
Parallel 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
DB-1303/BNT323 Dose Expansion 1
Experimental
Enrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 2
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 3
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 4
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 5
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 6
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 6 on Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 7
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 7 on Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 6
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 7
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 8
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 9
Experimental
Enrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 on Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 10
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W along with ritonavir or itraconazole to assess the DDI potential
Biological: DB-1303/BNT323
Drug: Ritonavir
Drug: Itraconazole
DB-1303/BNT323 Dose Expansion 11
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 12
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 in combination with Pertuzumab on Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
Drug: Pertuzumab Injection
DB-1303/BNT323 Dose Expansion 13
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 14
Experimental
China Only:Subjects who were previously treated with trastuzumab and taxane will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 15
Experimental
China Only: Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 16
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 17
Experimental
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 12
DB-1303/BNT323 Dose Expansion 13
DB-1303/BNT323 Dose Expansion 14
DB-1303/BNT323 Dose Expansion 15
DB-1303/BNT323 Dose Expansion 16
DB-1303/BNT323 Dose Expansion 17
DB-1303/BNT323 Dose Expansion 2
DB-1303/BNT323 Dose Expansion 3
DB-1303/BNT323 Dose Expansion 4
DB-1303/BNT323 Dose Expansion 5
DB-1303/BNT323 Dose Expansion 6
DB-1303/BNT323 Dose Expansion 7
DB-1303/BNT323 Dose Expansion 8
DB-1303/BNT323 Dose Expansion 9
DB-1303/BNT323 Dose Level 1
DB-1303/BNT323 Dose Level 2
DB-1303/BNT323 Dose Level 3
DB-1303/BNT323 Dose Level 4
DB-1303/BNT323 Dose Level 5
DB-1303/BNT323 Dose Level 6
DB-1303/BNT323 Dose Level 7
Pertuzumab Injection
Drug
Administered IV
DB-1303/BNT323 Dose Expansion 12
Ritonavir
Drug
Administered oral
DB-1303/BNT323 Dose Expansion 10
Itraconazole
Drug
Administered oral
DB-1303/BNT323 Dose Expansion 10
Up to follow-up period, approximately 1 year post-treatment
Phase 2: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0
Up to follow-up period, approximately 1 year post-treatment
Phase 2: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.
The percentage of subjects who had a best response of CR or PR, for Part 2 only which was maintained ≥4 weeks.
Up to follow-up period, approximately 1 year post-treatment
Phase 2 (Dose Expansion 10 only): To evaluate the effect of ritonavir on DB-1303 and P1003 PK in subjects with HER2-expressing, HER2-amplified, or HER2-mutated advanced solid malignant tumors
Maximum observed plasms concentration (Cmax) and Area under the concentration-time curve from 0 to infinity of DB-1303 and P1003 (+/- Ritonavir)
up to safety follow-up visit, approx. 35 days post-treatment
Phase 2 (Dose Expansion 10 only): To evaluate the effect of itraconazole on DB-1303 and P1003 PK in subjects with HER2-expressing, HER2-amplified, or HER2-mutated advanced solid malignant tumors.
Maximum observed plasms concentration (Cmax) and Area under the concentration-time curve from 0 to infinity of DB-1303 and P1003 (+/- Itraconazole)
up to safety follow-up visit, approx. 35 days post-treatment
Maximum observed plasma concentration (Cmax) of DB-1303
Up to safety follow up visit, approx. 35 days post-treatment
Phase 1 & Phase 2: Pharmacokinetic-Tmax
Time to Cmax of DB-1303
Up to safety follow up visit, approx. 35 days post-treatment
Phase 1 & Phase 2: Pharmacokinetic-T1/2
Terminal elimination half-life
Up to safety follow up visit, approx. 35 days post-treatment
Phase 1 & Phase 2: Pharmacokinetic-Ctrough
Trough concentration of DB-1303
Up to safety follow up visit, approx. 35 days post-treatment
Phase 1 & Phase 2: Pharmacodynamics-ADA
Data gathered from blood to determine Levels of anti-drug antibody (ADA) against DB 1303 in serum compared to baseline.
Up to safety follow up visit, approx. 35 days post-treatment
Phase 1 & 2: Disease Control Rate (DCR) as assessed by RECIST 1.1
Proportion of participants who had a best response rating of CR or PR, or SD using RECIST V1.1.
Up to follow-up period, approximately 1 year post-treatment
Phase 1 & 2: Duration of Response (DoR) as assessed by RECIST 1.1
The duration of time from date of first CR or PR to date of progressive disease or death due to any cause, whichever comes first using RECIST V1.1
Up to follow-up period, approximately 1 year post-treatment
Phase 1 & 2: Time to Response (TTR) as assessed by RECIST 1.1
The duration of time when receiving the first dose of study drug to the first date that is evaluated as either CR or PR using RECIST V1.1
Up to follow-up period, approximately 1 year post-treatment
Phase 2: Time on Therapy
The duration of time from participant receiving first dose of study drug to the last dose + 21 days
Up to 21 days after the participant's last dose
Phase 2: Percent change in target lesions as assessed by RECIST 1.1
The percent change in the participant's target lesions from baseline to last study scan using RECIST V1.1
Up to follow-up period, approximately 1 year post-treatment
Phase 1 and 2 Cohort b only: Progression-Free Survival
Time from subject receiving the first dose to disease progression or death by any cause
Up to follow-up period, approximately 1 year post-treatment
Phase 1 and 2 Cohort b only: Overall Survival
Time from subject receiving the first dose to death by any cause
Up to follow-up period, approximately 1 year post-treatment
Phase I: Percentage of Objective Response Rate (ORR) as assessed by investigator based on RECIST 1.1
The percentage of subjects who had a best response of CR or PR
Up to follow-up period, approximately 1 year post-treatment
Phase 2 Cohort b Only: Percentage of ORR as assessed by IRC and as assessed by investigator based on RECIST 1.1 for HER2-expressing subjects and in subjects with prior ICI treatment
The percentage of subjects who had a best response of CR or PR, for Cohort 2b only
Up to follow-up period, approximately 1 year post-treatment
To evaluate the safety of DB-1303 with/without ritonavir or itraconazole
Percentage of Participants with Serious Adverse Events (SAEs), Treatment Emergent Adverse Events (TEAE), TEAEs >/= G3, or TEAEs leading to dose reduction, interruption or discontinuation, Adverse Events of Special Interest, (AESIs), abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).
Up to follow-up period, approximately 1 year post-treatment
California Research Institute
Active, not recruiting
Los Angeles
California
90027
United States
Sharp Memorial Hospital
Active, not recruiting
San Diego
California
92123
United States
Washington Cancer Institute at MedStar Washington Hospital Center
Active, not recruiting
Washington D.C.
District of Columbia
20010
United States
Advanced Research LLC
Active, not recruiting
Coral Springs
Florida
33065
United States
The Oncology Institute of Hope and Innovation
Active, not recruiting
Lakeland
Florida
33812
United States
D&H Cancer Research Center LLC
Active, not recruiting
Margate
Florida
33063
United States
HCA Mercy Hospital
Withdrawn
Miami
Florida
33133
United States
BRCR Medical Center Inc.
Active, not recruiting
Plantation
Florida
33322
United States
BRCR Medical Center Inc.
Active, not recruiting
Tamarac
Florida
33321
United States
Southeastern Regional Medical Center, LLC
Active, not recruiting
Newnan
Georgia
30265
United States
Kapi'olani Medical Center for Women and Children
Active, not recruiting
Honolulu
Hawaii
96826
United States
University of Chicago
Active, not recruiting
Chicago
Illinois
60637
United States
Women's Cancer Care
Withdrawn
Covington
Louisiana
70433
United States
Holy Cross Hospital
Withdrawn
Silver Spring
Maryland
20910
United States
Massachusetts General Hospital
Active, not recruiting
Boston
Massachusetts
02214
United States
Beth Israel Deaconess Medical Center
Active, not recruiting
Boston
Massachusetts
02215
United States
Profound Research LLC/Michigan Hematology & Oncology Consultants
Withdrawn
Dearborn
Michigan
48126
United States
David C. Pratt Cancer Center
Active, not recruiting
St Louis
Missouri
63141
United States
Women's Cancer Center of Nevada
Withdrawn
Las Vegas
Nevada
89106
United States
Northwell Health
Withdrawn
Lake Success
New York
11042
United States
Laura & Isaac Perlmutter Cancer Center at NYC Langone Health
Active, not recruiting
New York
New York
10016
United States
Memorial Sloan Kettering Cancer Center
Active, not recruiting
New York
New York
10065
United States
North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood Specialists