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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05957536




Registration number
NCT05957536
Ethics application status
Date submitted
7/07/2023
Date registered
24/07/2023
Date last updated
23/05/2024

Titles & IDs
Public title
A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
Scientific title
A Phase 1, Open-label Dose Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-001 Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors.
Secondary ID [1] 0 0
D3L-001-100
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HER-2 Positive Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - D3L-001

Experimental: D3L-001 - Part 1 Dose Escalation in subjects with HER2-positive advanced solid tumors
Cohort 1 (starting dose)
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Part 2 Dose Expansion
Cohort A for subjects with HER2-positive advanced breast cancer
Cohort B for subjects with HER2-positive advanced gastric cancer/gastroesophageal junction cancer


Other interventions: D3L-001
Intravenous administration
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
Screening until Safety Follow Up visit (30 days after the last dose)
Primary outcome [2] 0 0
Maximum Tolerated Dose based on Dose-Limiting Toxicities (DLTs)
Timepoint [2] 0 0
At the end of Cycle 1 (each cycle is 21 days).
Secondary outcome [1] 0 0
D3L-001 minimum serum concentration (Ctrough)
Timepoint [1] 0 0
First dose up to 6 months
Secondary outcome [2] 0 0
D3L-001 maximum observed plasma concentration (Cmax)
Timepoint [2] 0 0
First dose up to 6 months
Secondary outcome [3] 0 0
D3L-001 time to maximum plasma concentration (tmax)
Timepoint [3] 0 0
First dose up to 6 months
Secondary outcome [4] 0 0
D3L-001 half-life (t1/2)
Timepoint [4] 0 0
First dose up to 6 months
Secondary outcome [5] 0 0
D3L-001 area under the concentration-time curve (AUC)
Timepoint [5] 0 0
First dose up to 6 months
Secondary outcome [6] 0 0
Incidence of anti-drug antibodies (ADA) to D3L-001
Timepoint [6] 0 0
First dose up to 6 months
Secondary outcome [7] 0 0
Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Timepoint [7] 0 0
Until disease progression or end of treatment (up to approximately 24 months)
Secondary outcome [8] 0 0
Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Timepoint [8] 0 0
Until disease progression or end of treatment (up to approximately 24 months)
Secondary outcome [9] 0 0
Disease control rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1
Timepoint [9] 0 0
Until disease progression or end of treatment (up to approximately 24 months)
Secondary outcome [10] 0 0
Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Timepoint [10] 0 0
Until disease progression or end of treatment (up to approximately 24 months)
Secondary outcome [11] 0 0
Pre- and post-dose levels of CD47 receptor occupancy in particular cell types from peripheral blood
Timepoint [11] 0 0
First dose up to 6 months

Eligibility
Key inclusion criteria
- Subject must have documented HER2 positivity (determined by immunohistochemistry
[IHC], in situ hybridization [ISH], Next Generation Sequencing [NGS] or other analysis
techniques as appropriate).

- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
1.

- Subject must have left ventricular ejection fraction (LVEF) =50% by either
echocardiography (ECHO) or multiple-gated acquisition (MUGA) within the screening
period.

- Subject must have adequate organ and marrow function within the screening period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has any prior treatment with anti-CD47 or SIRPa agent.

- Subject has major surgery or radiotherapy, immunostimulatory agents, investigational
agents, or any other anticancer treatment including chemotherapy, targeted therapy,
biologics that is not completed 28 days before first dose of study medication.

- Subject has immunosuppressive medication that is not completed 14 days before the
first dose of study medication.

- Subject has uncontrolled intercurrent illness that would limit compliance with study
requirements, substantially increase risk of incurring AEs, or compromise the ability
of the subject to give written informed consent.

- Subject has unresolved treatment-related toxicities from previous anticancer therapy
of NCI CTCAE Grade =2 (with exception of vitiligo or alopecia).

- Judgment by the Investigator that the subject should not participate in the study if
the subject is unlikely to comply with study procedures, restrictions, and
requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/03/2026
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
D3 Bio Investigative Site - Sydney
Recruitment hospital [2] 0 0
D3 Bio Investigative Site - Malvern
Recruitment postcode(s) [1] 0 0
2109 - Sydney
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
China
State/province [4] 0 0
Heilongjiang
Country [5] 0 0
China
State/province [5] 0 0
Shanghai

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
D3 Bio (Wuxi) Co., Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion
Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics
(PD), immunogenicity, and preliminary anti-tumor activity of D3L-001 in subjects with
HER2-positive advanced solid tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05957536
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
Medical Director
Address 0 0
Country 0 0
Phone 0 0
+86 21 61635900
Fax 0 0
Email 0 0
D3bio_CT@d3bio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05957536