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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07141706




Registration number
NCT07141706
Ethics application status
Date submitted
18/08/2025
Date registered
26/08/2025
Date last updated
26/08/2025

Titles & IDs
Public title
A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors
Scientific title
A Phase 1a/1b, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1317 in Participants With Selected Advanced/Metastatic Solid Tumors
Secondary ID [1] 0 0
DB-1317-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DB-1317

Experimental: DB-1317 Dose Level 1 - Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 1 on Day 1 of each cycle Q3W

Experimental: DB-1317 Dose Level 2 - Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 2 on Day 1 of each cycle Q3W

Experimental: DB-1317 Dose Level 3 - Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 3 on Day 1 of each cycle Q3W

Experimental: DB-1317 Dose Level 4 - Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 4 on Day 1 of each cycle Q3W

Experimental: DB-1317 Dose Level 5 - Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 5 on Day 1 of each cycle Q3W

Experimental: DB-1317 Dose Expansion 1 - Subjects with advanced/unresectable, or metastatic Gastric cancer (GC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317

Experimental: DB-1317 Dose Expansion 2 - Subjects with advanced/unresectable, or metastatic colorectal cancer (CRC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317

Experimental: DB-1317 Dose Expansion 3 - Subjects with advanced/unresectable, or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317


Treatment: Drugs: DB-1317
Administered I.V.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1a: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs
Timepoint [1] 0 0
up to 21 days after Cycle 1 Day 1
Primary outcome [2] 0 0
Phase 1a: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Timepoint [2] 0 0
Up to follow-up period, approximately 1 year post-treatment
Primary outcome [3] 0 0
Phase 1a: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Timepoint [3] 0 0
Up to follow-up period, approximately 1 year post-treatment
Primary outcome [4] 0 0
Maximum Tolerated Dose (MTD) of DB-1317
Timepoint [4] 0 0
Up to the completion of Phase 1a (assessed up to 12 months)
Primary outcome [5] 0 0
Recommended Phase 1b Dose (RP2D) of DB-1317
Timepoint [5] 0 0
Up to the completion of Phase 1a (assessed up to 12 months)
Primary outcome [6] 0 0
Phase 1b: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.
Timepoint [6] 0 0
Up to follow-up period, approximately 1 year post-treatment
Primary outcome [7] 0 0
Phase 1b: Percentage of participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Timepoint [7] 0 0
Up to follow-up period, approximately 1 year post-treatment
Primary outcome [8] 0 0
Phase 1b: Objective Response Rate (ORR) as determined by investigator
Timepoint [8] 0 0
Up to follow-up period, approximately 1 year post-treatment
Primary outcome [9] 0 0
Phase 1b: duration of response (DoR)
Timepoint [9] 0 0
Up to follow-up period, approximately 1 year post-treatment
Primary outcome [10] 0 0
Phase 1b: disease-control rate (DCR)
Timepoint [10] 0 0
Up to follow-up period, approximately 1 year post-treatment
Primary outcome [11] 0 0
Phase 1b: Time to Response (TTR)
Timepoint [11] 0 0
Up to follow-up period, approximately 1 year post-treatment
Secondary outcome [1] 0 0
Phase 1a: Objective response rate (ORR)
Timepoint [1] 0 0
Up to follow-up period, approximately 1 year post-treatment
Secondary outcome [2] 0 0
Phase 1a: duration of response (DoR)
Timepoint [2] 0 0
Up to follow-up period, approximately 1 year post-treatment
Secondary outcome [3] 0 0
Phase 1a: disease-control rate (DCR)
Timepoint [3] 0 0
Up to follow-up period, approximately 1 year post-treatment
Secondary outcome [4] 0 0
Phase 1a: Time to Response (TTR)
Timepoint [4] 0 0
Up to follow-up period, approximately 1 year post-treatment
Secondary outcome [5] 0 0
Phase 1a & Phase 1b: Progression Free Survival (PFS)
Timepoint [5] 0 0
Up to follow-up period, approximately 1 year post-treatment
Secondary outcome [6] 0 0
Phase 1a & Phase 1b: Overall Survival (OS)
Timepoint [6] 0 0
From date of first dose until the date of death or lost to follow up, approximately 1 year post-treatment
Secondary outcome [7] 0 0
Phase 1a: Prostate-specific antigen (PSA)
Timepoint [7] 0 0
From date of first dose until the date of first PSA progression, approximately 1 year post-treatment
Secondary outcome [8] 0 0
Phase 1a & Phase 1b: Pharmacokinetic-AUC
Timepoint [8] 0 0
within 3 cycles (each cycle is 21 days)
Secondary outcome [9] 0 0
Phase 1a & Phase 1b: Pharmacokinetic-Cmax
Timepoint [9] 0 0
within 3 cycles (each cycle is 21 days)
Secondary outcome [10] 0 0
Phase 1a & Phase 1b: Pharmacokinetic-Tmax
Timepoint [10] 0 0
within 3 cycles (each cycle is 21 days)
Secondary outcome [11] 0 0
Phase 1a & Phase 1b: Pharmacokinetic-Cthrough
Timepoint [11] 0 0
within 6 cycles (each cycle is 21 days)
Secondary outcome [12] 0 0
Phase 1a & Phase 1b: Anti-drug antibody (ADA) prevalence
Timepoint [12] 0 0
Up to follow-up period, approximately 1 year post-treatment
Secondary outcome [13] 0 0
Phase 1a & Phase 1b: ADA incidence
Timepoint [13] 0 0
Up to follow-up period, approximately 1 year post-treatment

Eligibility
Key inclusion criteria
Key

1. Male or female adults
2. Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments.
3. Only applicable to backfilling participants in Phase 1a and participants in Phase 1b: At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria. Participants with non-measurable disease are allowed for CRPC participants.
4. Has a life expectancy of = 3 months.
5. Has an ECOG PS of 0-1.
6. Has LVEF = 50% within 28 days before enrollment.
7. Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of ADAM9 expression level and other biomarkers if no contra-indication.
8. Male and female participants of reproductive/childbearing potential must agree to use adequate contraceptive methods

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior treatment with ADAM9 targeted therapy.
2. Prior treatment with antibody-drug conjugate with topoisomerase I inhibitor.
3. Has a medical history of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment.
4. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
5. Has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG
6. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to > 470 ms in males and females
7. Has a history of (non-infectious) ILD/pneumonitis
8. Has a lung-specific intercurrent clinically significant illness
9. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.
10. Known human immunodeficiency virus (HIV) infection;Chronic, active, or uncontrolled hepatitis B;
11. Known chronic, active, or uncontrolled hepatitis C
12. Has clinically significant corneal disease.
13. Has clinically active brain metastases
14. Has unresolved toxicities from previous anticancer therapy Concurrent malignancy < 3 years.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Phase
Phase 1
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
1/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
183
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
AUS01-0 - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
DualityBio Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Lily Hu
Address 0 0
DualityBio Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Xena Wu
Address 0 0
Country 0 0
Phone 0 0
01067228087
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT07141706