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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06554795




Registration number
NCT06554795
Ethics application status
Date submitted
6/08/2024
Date registered
15/08/2024

Titles & IDs
Public title
First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors
Scientific title
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants With Advanced/Metastatic Solid Tumors
Secondary ID [1] 0 0
DB-1419-O-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor, Adult 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DB-1419

Experimental: Dose Level 1 - Enrolled subjects will receive DB-1419 at Dose Level 1

Experimental: Dose Level 2 - Enrolled subjects will receive DB-1419 at Dose Level 2

Experimental: Dose Level 3 - Enrolled subjects will receive DB-1419 at Dose Level 3

Experimental: Dose Level 4 - Enrolled subjects will receive DB-1419 at Dose Level 4

Experimental: Dose Level 5 - Enrolled subjects will receive DB-1419 at Dose Level 5

Experimental: Dose Level 6 - Enrolled subjects will receive DB-1419 at Dose Level 6

Experimental: Dose Expansion 1 -

Experimental: Dose Expansion 2 -

Experimental: Dose Expansion 3 -

Experimental: Dose Expansion 4 -

Experimental: Dose Expansion 5 -

Experimental: Dose Expansion 6 -

Experimental: Dose Expansion 7 -

Experimental: Dose Expansion 8 -


Treatment: Drugs: DB-1419
Administered Injection of Vein (I.V.)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1/2a: Percentage of Participants with Adverse events (AE) serious AE (SAE)
Timepoint [1] 0 0
Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first
Primary outcome [2] 0 0
Phase 1/2a: Percentage of Participants with serious AE (SAE)
Timepoint [2] 0 0
Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first
Primary outcome [3] 0 0
Phase 1a: Maximum Tolerated Dose (MTD)
Timepoint [3] 0 0
From first study treatment administration until the initiation of Phase1b/2a, approximately up to 12 months.
Primary outcome [4] 0 0
Phase 1a: Recommended Phase 2 Dose (RP2D)
Timepoint [4] 0 0
From first study treatment administration until the initiation of Phase 1b/2a, approximately up to 12 months.
Primary outcome [5] 0 0
Phase 1b/2a: Objective Response Rate (ORR) determined by Investigator per RECIST v1.1
Timepoint [5] 0 0
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.
Secondary outcome [1] 0 0
Phase 1a: ORR determined from tumor assessments by Investigator per RECIST v1.1
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Phase 1/2a: Progression free survival (PFS) determined from tumor assessments by Investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Phase 1/2a: OS
Timepoint [3] 0 0
From the start date of study drug to the date of death due to any cause, whichever occurs first, approximately up to 12 months after last patient first dose.
Secondary outcome [4] 0 0
Phase 1/2a: AUC0-last
Timepoint [4] 0 0
within 8 cycles (each cycle is 21 days or 14 days)
Secondary outcome [5] 0 0
Phase 1/2a: AUC0-tau
Timepoint [5] 0 0
within 8 cycles (each cycle is 21 days or 14 days)
Secondary outcome [6] 0 0
Phase 1/2a: AUCinf
Timepoint [6] 0 0
within 8 cycles (each cycle is 21 days or 14 days)
Secondary outcome [7] 0 0
Phase 1/2a: Cmax
Timepoint [7] 0 0
within 8 cycles (each cycle is 21 days or 14 days)
Secondary outcome [8] 0 0
Phase 1/2a: Tmax
Timepoint [8] 0 0
within 8 cycles (each cycle is 21 days or 14 days)
Secondary outcome [9] 0 0
Phase 1/2a: Ctrough
Timepoint [9] 0 0
within 8 cycles (each cycle is 21 days or 14 days)
Secondary outcome [10] 0 0
Phase 1/2a: ADA prevalence
Timepoint [10] 0 0
within 8 cycles (each cycle is 21 days or 14 days)
Secondary outcome [11] 0 0
Phase 1/2a: ADA incidence
Timepoint [11] 0 0
within 8 cycles (each cycle is 21 days or 14 days)

Eligibility
Key inclusion criteria
1. Adults aged = 18 years at the time of voluntarily signing informed consent.
2. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available.
3. At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria (Only applicable to backfill participants in phase 1a and participants in phase 1b/2a). CRPC participants with bone-only disease may be eligible on a case-by-case basis after discussion with the Medical Monitor.
4. Has a life expectancy of = 3 months.
5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
6. Has LVEF = 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
7. Has adequate organ function within 7 days prior to the first dose of study treatment.
8. Has adequate treatment washout period prior to the first dose of study treatment.
9. Is willing to provide pre-existing resected tumor samples when available or undergo fresh tumor biopsy if feasible for the measurement of B7-H3/PD-L1 level and other biomarkers if no contraindication.

Note: there is no minimum B7-H3/PD-L1 expression level mandatory for entry into the study.
10. 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.
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 B7-H3 targeted therapy.
2. Has a medical history of symptomatic congestive heart failure (New York Heart Association [NYHA] classes II-IV or serious cardiac arrhythmia requiring treatment.
3. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
4. 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.
5. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis which needs glucocorticoids and antibiotics) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
6. Has a history of underlying pulmonary disorder including, but not limited to, pulmonary emboli within 3 months of the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically significant pulmonary compromise or requirement for supplemental oxygen.
7. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
8. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals within 2 weeks before first dose of study treatment.
9. Know human immunodeficiency virus (HIV) infection.
10. Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with asymptomatic CNS metastases who are radiologically and neurologically stable for at least 4 weeks following CNS-directed therapy (defined as 2 brain images, same imaging modality, both of which are obtained after treatment to the brain metastases; these imaging scans should be obtained at least 4 weeks apart and show no evidence of intracranial progression), and are on stable or decreasing doses of corticosteroids equivalent to =10 mg/day prednisone are eligible for study entry.

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
Parallel
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
1/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
AUS02-0 - Nedlands
Recruitment hospital [2] 0 0
AUS03-0 - North Ryde
Recruitment hospital [3] 0 0
AUS01-0 - Randwick
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment postcode(s) [2] 0 0
- North Ryde
Recruitment postcode(s) [3] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
China
State/province [4] 0 0
Ha'erbin
Country [5] 0 0
China
State/province [5] 0 0
Jinan
Country [6] 0 0
China
State/province [6] 0 0
Luoyang
Country [7] 0 0
China
State/province [7] 0 0
Shanghai

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
Phyllis Wu
Address 0 0
Country 0 0
Phone 0 0
+86 13501633946
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT06554795