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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05410145




Registration number
NCT05410145
Ethics application status
Date submitted
25/05/2022
Date registered
8/06/2022
Date last updated
4/11/2024

Titles & IDs
Public title
A Study of D3S 001 Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors with a KRAS P.G12C Mutation
Scientific title
A Phase 1/2, Open Label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S 001 Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors with a KRAS P.G12C Mutation
Secondary ID [1] 0 0
2023-508517-16
Secondary ID [2] 0 0
D3S-001-100
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
KRAS P.G12C 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - D3S-001
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cetuximab

Experimental: D3S-001 monotherapy - Part 1: Dose Escalation, D3S-001 administered orally.

Part 2 and Part 3a Arm C: Dose Expansion, D3S-001 administered orally in selected cancer type patients.

Experimental: D3S-001 and pembrolizumab - Part 3a Arm A: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients.

Pembrolizumab administered intravenously.

Experimental: D3S-001 and platinum doublet chemotherapy (cisplatin + pemetrexed or carboplatin + permetrexed) - Part 3a Arm B: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients.

Cisplatin + pemetrexed administered intravenously

or

Carboplatin + permetrexed administered intravenously

Experimental: D3S-001 and Cetuximab - Part 3b: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients.

Cetuximab administered intravenously.


Treatment: Drugs: D3S-001
Oral

Treatment: Drugs: Pembrolizumab
Intravenous

Treatment: Drugs: Cisplatin
Intravenous

Treatment: Drugs: Carboplatin
Intravenous

Treatment: Drugs: Pemetrexed
Intravenous

Treatment: Drugs: Cetuximab
Intravenous
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
From 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-001 maximum observed plasma concentration (Cmax)
Timepoint [1] 0 0
Up to 24 months.
Secondary outcome [2] 0 0
D3S-001 time to maximum plasma concentration (tmax)
Timepoint [2] 0 0
Up to 24 months.
Secondary outcome [3] 0 0
D3S-001 half-life (t1/2)
Timepoint [3] 0 0
Up to 24 months.
Secondary outcome [4] 0 0
D3S-001 area under the concentration-time curve (AUC)
Timepoint [4] 0 0
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
Up to 24 months.
Secondary outcome [6] 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 [6] 0 0
Up to 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
Up to 24 months.
Secondary outcome [8] 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 [8] 0 0
Up to 24 months.

Eligibility
Key inclusion criteria
Inclusion:

* Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.
* Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.
* Subject must have measurable disease per RECIST v1.1.
* Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 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.
* Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).

Other protocol 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
392
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
D3 Bio Investigative Site - Sydney
Recruitment hospital [2] 0 0
D3 Bio Investigative Site - Malvern
Recruitment hospital [3] 0 0
D3 Bio Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2109 - Sydney
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
China
State/province [7] 0 0
Beijing
Country [8] 0 0
China
State/province [8] 0 0
Guangdong
Country [9] 0 0
China
State/province [9] 0 0
Hangzhou
Country [10] 0 0
China
State/province [10] 0 0
Heilongjiang
Country [11] 0 0
China
State/province [11] 0 0
Hubei
Country [12] 0 0
China
State/province [12] 0 0
Jiangxi
Country [13] 0 0
China
State/province [13] 0 0
Liaoning
Country [14] 0 0
China
State/province [14] 0 0
Shandong
Country [15] 0 0
China
State/province [15] 0 0
Shanghai
Country [16] 0 0
China
State/province [16] 0 0
Sichuan
Country [17] 0 0
China
State/province [17] 0 0
Zhejiang
Country [18] 0 0
Hong Kong
State/province [18] 0 0
Sha Tin
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
North Chungcheong
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul

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 is a first-in-human (FIH), multicenter, open-label, dose-escalation, and dose-expansion Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of D3S-001 or combination therapy in subjects with advanced KRAS p.G12C mutant solid tumors. D3S-001 will be taken daily by oral administration in 21-day treatment cycles.
Trial website
https://clinicaltrials.gov/study/NCT05410145
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cheng Chen, MD
Address 0 0
D3 Bio (Wuxi) Co., Ltd
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/NCT05410145