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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06953089




Registration number
NCT06953089
Ethics application status
Date submitted
9/04/2025
Date registered
1/05/2025

Titles & IDs
Public title
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Scientific title
A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors
Secondary ID [1] 0 0
DB-1311-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DB-1311/BNT324
Treatment: Drugs - BNT327
Treatment: Drugs - DB-1305/BNT325

Experimental: Part 1 Cohort 1, DB-1311/BNT324+ BNT327 combination therapy - Escalating combination dose levels of DB-1311/BNT324 and BNT327 to define RP2D and RP2D-1 in target population.

Experimental: Part 1 Cohort 2, DB-1311/BNT324+ DB-1305 /BNT325 combination therapy - Escalating combination dose levels of DB-1311/BNT324 and DB-1305/BNT325 to define RP2D and RP2D-1 in target population.

Experimental: Part 2 Arm 1: RP2D of DB-1311/BNT324 + BNT327 - In participants with unresectable advanced/metastatic HCC

Experimental: Part 2 Arm 2: RP2D of DB-1311/BNT324 + BNT327 - In participants with unresectable advanced/ metastatic cervical cancer (CC)

Experimental: Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327 - In participants with unresectable advanced/metastatic melanoma

Experimental: Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327 and RP2D-1 of DB-1311/BNT324 + BNT327 - In participants with recurrent/metastatic HNSCC

Experimental: Part 2 Arm 5: RP2D of DB-1311/BNT324 +DB-1305/BNT325 and RP2D-1 of DB-1311/BNT324 +DB-1305/BNT325 - In participants with advanced/unresectable metastatic NSCLC


Treatment: Drugs: DB-1311/BNT324
Administered I.V.

Treatment: Drugs: BNT327
Administered I.V.

Treatment: Drugs: DB-1305/BNT325
Administered I.V.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of participants with Dose Limiting Toxicities (DLTs).
Timepoint [1] 0 0
During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days
Primary outcome [2] 0 0
Part 1 and Part 2: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs)
Timepoint [2] 0 0
From the time of the first dose of IMP to 90 days after the last IMP dose (For BNT327 Combo) or 30 days after last dose (For DB-1305/BNT325 Combo) or until new anticancer therapy is started, whichever occurs first
Primary outcome [3] 0 0
ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST 1.1 based on the investigator's assessment).
Timepoint [3] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [1] 0 0
Part 1: Objective response rate (ORR), defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST 1.1 based on the investigator's assessment).
Timepoint [1] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [2] 0 0
Part 1 and 2: Duration of response (DoR) per RECIST 1.1 based on the investigator's assessment.
Timepoint [2] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [3] 0 0
Part 1 and 2: Overall survival (OS)
Timepoint [3] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [4] 0 0
Part 1 and 2: Maximum observed concentration (Cmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with BNT327.
Timepoint [4] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [5] 0 0
Part 1 and 2: Anti-drug antibody (ADA) prevalence: the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline).
Timepoint [5] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [6] 0 0
Part 1 and 2: Disease-control rate (DCR) per RECIST 1.1 based on the investigator's assessment.
Timepoint [6] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [7] 0 0
Part 1 and 2: Time to response (TTR) per RECIST 1.1 based on the investigator's assessment.
Timepoint [7] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [8] 0 0
Part 1 and 2: Progression-free survival (PFS) per RECIST 1.1 based on the investigator's assessment.
Timepoint [8] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [9] 0 0
Part 1 and Part 2: ADA incidence: the proportion of participants having treatment-emergent ADA.
Timepoint [9] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [10] 0 0
Part 1 and 2: Maximum observed concentration (Cmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325.
Timepoint [10] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [11] 0 0
Part 1 and 2: Time to reach maximum observed concentration (Tmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with BNT327.
Timepoint [11] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [12] 0 0
Part 1 and 2: Time to reach maximum observed concentration (Tmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325.
Timepoint [12] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [13] 0 0
Part 1 and 2: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with BNT327.
Timepoint [13] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [14] 0 0
Part 1 and 2: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325.
Timepoint [14] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [15] 0 0
Part 1 and 2: Terminal elimination half-life (t1/2) of DB-1311/BNT324 total ADC, total antibody and unconjugated P1021 in combination with BNT327.
Timepoint [15] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcome [16] 0 0
Part 1 and 2: Terminal elimination half-life (t1/2) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325.
Timepoint [16] 0 0
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months

Eligibility
Key inclusion criteria
* Adults aged = 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent.
* At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria.
* Has a life expectancy of = 3 months.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
* Has adequate organ function within 7 days prior to enrollment/randomization,
* Has adequate treatment washout period prior to the first dose of trial treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with B7H3 targeted therapy.
* Prior treatment with antibody-drug conjugate with topoisomerase inhibitor.
* Is a candidate to locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment.
* Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs.



* 1. Prior treatment with B7H3 targeted therapy.
* Prior treatment with antibody-drug conjugate with topoisomerase inhibitor.
* Is a candidate to locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment.
* Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs.
* Has uncontrolled or significant cardiovascular disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2030
Actual
Sample size
Target
440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Research Site AUS02-0 - North Ryde BC
Recruitment postcode(s) [1] 0 0
2109 - North Ryde BC
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
South Carolina
Country [3] 0 0
China
State/province [3] 0 0
Anhui
Country [4] 0 0
China
State/province [4] 0 0
Beijing
Country [5] 0 0
China
State/province [5] 0 0
Heilongjiang
Country [6] 0 0
China
State/province [6] 0 0
Henan
Country [7] 0 0
China
State/province [7] 0 0
Hubei
Country [8] 0 0
China
State/province [8] 0 0
Jiangxi
Country [9] 0 0
China
State/province [9] 0 0
Shanghai
Country [10] 0 0
Taiwan
State/province [10] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
DualityBio Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
BioNTech SE
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul Guo
Address 0 0
Country 0 0
Phone 0 0
636-288-5581
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06953089