Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05150691
Registration number
NCT05150691
Ethics application status
Date submitted
11/11/2021
Date registered
9/12/2021
Date last updated
19/10/2023
Titles & IDs
Public title
A Study of DB-1303 in Advanced/Metastatic Solid Tumors
Query!
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-1303 in Patients With Advanced/Metastatic Solid Tumors
Query!
Secondary ID [1]
0
0
DB-1303-O-1001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
HER2-positive Advanced Solid Tumor
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - DB-1303
Treatment: Drugs - Pertuzumab Injection
Treatment: Drugs - Ritonavir
Treatment: Drugs - Itraconazole
Experimental: DB-1303 Dose Level 1 - Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 1 on Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Level 2 - Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 2 on Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Level 3 - Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 3 on Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Level 4 - Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 4 on Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Level 5 - Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 5 on Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Expansion 1 - Enrolled Subjects will be randomized to receive a single-dose of DB-1303 on a selected dose level 1 or dose level 2 Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Expansion 2 - Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Expansion 3 - Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Expansion 4 - Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Expansion 5 - Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Level 6 - Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 6 on Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Level 7 - Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 7 on Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Expansion 6 - Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Expansion 7 - Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Expansion 8 - Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Expansion 9 - Enrolled Subjects will be randomized to receive a single-dose of DB-1303 on a selected dose level 1 or dose level 2 on Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Expansion 10 - Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W along with ritonavir and itraconazole to assess the DDI potential
Experimental: DB-1303 Dose Expansion 11 - Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Expansion 12 - Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level 1 or dose level 2 in combination with Pertuzumab on Day 1 of each cycle Q3W
Experimental: DB-1303 Dose Expansion 13 - Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Other interventions: DB-1303
Administered IV
Treatment: Drugs: Pertuzumab Injection
Administered IV
Treatment: Drugs: Ritonavir
Administered oral
Treatment: Drugs: Itraconazole
Administered oral
Query!
Intervention code [1]
0
0
Other interventions
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.
Query!
Assessment method [1]
0
0
Percentage of participants in Part 1 with DLTs
Query!
Timepoint [1]
0
0
up to 21 days after C1D1
Query!
Primary outcome [2]
0
0
Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) ot Treatment Emergent Adverse Event of Special Interest include those >/= G3 or leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0.
Query!
Assessment method [2]
0
0
Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0
Query!
Timepoint [2]
0
0
Up to follow-up period, approximately 1 year post-treatment
Query!
Primary outcome [3]
0
0
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Query!
Assessment method [3]
0
0
Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0
Query!
Timepoint [3]
0
0
Up to follow-up period, approximately 1 year post-treatment
Query!
Primary outcome [4]
0
0
Phase 1: Maximum Tolerated Dose (MTD) of DB-1303
Query!
Assessment method [4]
0
0
MTD on the data collected during Part 1
Query!
Timepoint [4]
0
0
12 months
Query!
Primary outcome [5]
0
0
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1303
Query!
Assessment method [5]
0
0
RP2D of DB-1303 based on the data collected during Part 1
Query!
Timepoint [5]
0
0
12 months
Query!
Primary outcome [6]
0
0
Phase 2: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) ot Treatment Emergent Adverse Event of Special Interest include those >/= G3 or leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0
Query!
Assessment method [6]
0
0
Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0
Query!
Timepoint [6]
0
0
Up to follow-up period, approximately 1 year post-treatment
Query!
Primary outcome [7]
0
0
Phase 2: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Query!
Assessment method [7]
0
0
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0
Query!
Timepoint [7]
0
0
Up to follow-up period, approximately 1 year post-treatment
Query!
Primary outcome [8]
0
0
Phase 2: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.
Query!
Assessment method [8]
0
0
The percentage of subjects who had a best response rating of CR and PR, for Part 2 only which was maintained =4 weeks.
Query!
Timepoint [8]
0
0
Up to follow-up period, approximately 1 year post-treatment
Query!
Secondary outcome [1]
0
0
Phase 1 & Phase 2: Pharmacokinetic-AUC
Query!
Assessment method [1]
0
0
Area under the concentration-time curve from time 0 to infinity of DB-1303
Query!
Timepoint [1]
0
0
Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit
Query!
Secondary outcome [2]
0
0
Phase 1 & Phase 2: Pharmacokinetic-Cmax
Query!
Assessment method [2]
0
0
Maximum observed plasma concentration (Cmax) of DB-1303
Query!
Timepoint [2]
0
0
Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit
Query!
Secondary outcome [3]
0
0
Phase 1 & Phase 2: Pharmacokinetic-Tmax
Query!
Assessment method [3]
0
0
Time to Cmax of DB-1303
Query!
Timepoint [3]
0
0
Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit
Query!
Secondary outcome [4]
0
0
Phase 1 & Phase 2: Pharmacokinetic-T1/2
Query!
Assessment method [4]
0
0
Terminal elimination half-life
Query!
Timepoint [4]
0
0
Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit
Query!
Secondary outcome [5]
0
0
Phase 1 & Phase 2: Pharmacokinetic-Ctrough
Query!
Assessment method [5]
0
0
Trough concentration of DB-1303
Query!
Timepoint [5]
0
0
Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit
Query!
Secondary outcome [6]
0
0
Phase 1 & Phase 2: Pharmacodynamics-ADA
Query!
Assessment method [6]
0
0
Data gathered from blood to determine Levels of anti-drug antibody (ADA) against DB 1303 in serum compared to baseline.
Query!
Timepoint [6]
0
0
Before infusion on C1D1, C1D15, Before infusion on day 1 of C2, C4, C6, C8, C10 and every 4 cycles until end of treatment, EOT visit, Safety FU Visit, and 60 and 90 days after last dose (if possible)
Query!
Secondary outcome [7]
0
0
Phase 1 & 2: Disease Control Rate (DCR) as assessed by RECIST 1.1
Query!
Assessment method [7]
0
0
Proportion of participants who had a best response rating of CR or PR, or SD using RECIST V1.1.
Query!
Timepoint [7]
0
0
Up to follow-up period, approximately 1 year post-treatment
Query!
Secondary outcome [8]
0
0
Phase 1 & 2: Duration of Response (DoR) as assessed by RECIST 1.1
Query!
Assessment method [8]
0
0
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
Query!
Timepoint [8]
0
0
Up to follow-up period, approximately 1 year post-treatment
Query!
Secondary outcome [9]
0
0
Phase 1 & 2: Time to Response (TTR) as assessed by RECIST 1.1
Query!
Assessment method [9]
0
0
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
Query!
Timepoint [9]
0
0
Up to follow-up period, approximately 1 year post-treatment
Query!
Secondary outcome [10]
0
0
Phase 2: Time on Therapy
Query!
Assessment method [10]
0
0
The duration of time from participant receiving first dose of study drug to the last dose + 21 days
Query!
Timepoint [10]
0
0
Up to 21 days after the participant's last dose
Query!
Secondary outcome [11]
0
0
Phase 2: Percent change in target lesions as assessed by RECIST 1.1
Query!
Assessment method [11]
0
0
The percent change in the participant's target lesions from baseline to last study scan using RECIST V1.1
Query!
Timepoint [11]
0
0
Up to follow-up period, approximately 1 year post-treatment
Query!
Secondary outcome [12]
0
0
Phase 2 Cohort b only: Progression-Free Survival
Query!
Assessment method [12]
0
0
Time from subject receiving the first dose to disease progression or death by any cause
Query!
Timepoint [12]
0
0
Up to follow-up period, approximately 1 year post-treatment
Query!
Secondary outcome [13]
0
0
Phase 2 Cohort b only: Overall Survival
Query!
Assessment method [13]
0
0
Time from subject receiving the first dose to death by any cause
Query!
Timepoint [13]
0
0
Up to follow-up period, approximately 1 year post-treatment
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
- 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1/Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
31/01/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/10/2025
Query!
Actual
Query!
Sample size
Target
631
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Query!
Recruitment hospital [1]
0
0
Macquarie Clinical Trials Unit - Sydney
Query!
Recruitment hospital [2]
0
0
Integrated Clinical Oncology Network Pty Ltd (Icon) - South Brisbane
Query!
Recruitment postcode(s) [1]
0
0
2109 - Sydney
Query!
Recruitment postcode(s) [2]
0
0
4101 - South Brisbane
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
District of Columbia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Hawaii
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Louisiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Massachusetts
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Missouri
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Ohio
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Oklahoma
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Tennessee
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Washington
Query!
Country [15]
0
0
China
Query!
State/province [15]
0
0
Anhui
Query!
Country [16]
0
0
China
Query!
State/province [16]
0
0
Beijing
Query!
Country [17]
0
0
China
Query!
State/province [17]
0
0
Changchun
Query!
Country [18]
0
0
China
Query!
State/province [18]
0
0
Guangdong
Query!
Country [19]
0
0
China
Query!
State/province [19]
0
0
Guangxi
Query!
Country [20]
0
0
China
Query!
State/province [20]
0
0
Hebei
Query!
Country [21]
0
0
China
Query!
State/province [21]
0
0
Hehan
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Henan
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Hubei
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Hunan
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Jiangsu
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Jiangxi
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Liaoning
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Shandong
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Shangdong
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Shanghai
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Tianjin
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Zhejiang
Query!
Country [33]
0
0
Puerto Rico
Query!
State/province [33]
0
0
Mayaguez
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
DualityBio Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and
tolerability of DB-1303 in subjects with advanced solid tumors that express HER2.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05150691
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Britney Winterberger
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+1-513-403-8568
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05150691
Download to PDF