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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05886920




Registration number
NCT05886920
Ethics application status
Date submitted
24/05/2023
Date registered
2/06/2023
Date last updated
6/06/2024

Titles & IDs
Public title
Study of D3S-002 as Monotherapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations
Scientific title
A Phase 1, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose of D3S-002 Monotherapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations
Secondary ID [1] 0 0
D3S-002-100
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors With MAPK Pathway Mutations 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - D3S-002

Experimental: D3S-002 - Dose Escalation, D3S-002 administered orally.


Treatment: Drugs: D3S-002
Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
First dose until 30 days after the last dose (or specified in the protocol)
Primary outcome [2] 0 0
Number of Participants With Dose-Limiting Toxicities (DLTs)
Timepoint [2] 0 0
From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.
Secondary outcome [1] 0 0
D3S-002 maximum observed plasma concentration (Cmax)
Timepoint [1] 0 0
First dose up to 24 months
Secondary outcome [2] 0 0
D3S-002 time to maximum plasma concentration (tmax)
Timepoint [2] 0 0
First dose up to 24 months
Secondary outcome [3] 0 0
D3S-002 half-life (t1/2)
Timepoint [3] 0 0
First dose up to 24 months
Secondary outcome [4] 0 0
D3S-002 area under the concentration-time curve (AUC)
Timepoint [4] 0 0
First dose up to 24 months
Secondary outcome [5] 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 [5] 0 0
Until disease progression or end of treatment (up to approximately 24 months)
Secondary outcome [6] 0 0
Disease control rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Timepoint [6] 0 0
Until disease progression or end of treatment (up to approximately 24 months)
Secondary outcome [7] 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 [7] 0 0
Until disease progression or end of treatment (up to approximately 24 months)

Eligibility
Key inclusion criteria
Inclusion:

* Subjects must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor with evidence of progressive disease.
* Subjects must have documented mitogen-activated protein kinase (MAPK) pathway mutation(s) within the last 5 years identified by a local test on tumor tissue or blood (eg, rat sarcoma (RAS), rapidly accelerated fibrosarcoma (RAF), and MAPK kinase (MAPKK) mutations).
* Subjects must be refractory to or intolerable with standard treatment, or have no available standard of care.
* Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* 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
Exclusion:

* Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.
* Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations 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).
* Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.
* Any concurrent chemotherapy, immunotherapy, targeted therapy, cell therapy, biologic or hormonal therapy and any medical devices for cancer treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
10/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
D3 Bio Investigative Site - Blacktown
Recruitment hospital [2] 0 0
D3 Bio Investigative Site - Bedford Park
Recruitment hospital [3] 0 0
D3 Bio Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
China
State/province [3] 0 0
Beijing
Country [4] 0 0
China
State/province [4] 0 0
Guangdong
Country [5] 0 0
China
State/province [5] 0 0
Heilong Jiang
Country [6] 0 0
China
State/province [6] 0 0
Shanghai
Country [7] 0 0
China
State/province [7] 0 0
Zhejiang

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 aims to assess the safety, tolerability, pharmacokinetics, and recommended phase 2 dose (RP2D) of D3S-002 given orally daily for 21-day cycles in adult subjects with advanced solid tumors with mitogen-activated protein kinase (MAPK) pathway mutations.
Trial website
https://clinicaltrials.gov/study/NCT05886920
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05886920