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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/NCT05410145
Registration number
NCT05410145
Ethics application status
Date submitted
25/05/2022
Date registered
8/06/2022
Date last updated
24/05/2024
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
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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
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Secondary ID [1]
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2023-508517-16
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Secondary ID [2]
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D3S-001-100
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
KRAS P.G12C
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events (AEs)
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Assessment method [1]
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Timepoint [1]
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From first dose until 30 days after the last dose (or specified in the protocol).
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Primary outcome [2]
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Number of Participants With Dose-Limiting Toxicities (DLTs)
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Assessment method [2]
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Timepoint [2]
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From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.
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Secondary outcome [1]
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D3S-001 maximum observed plasma concentration (Cmax)
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Assessment method [1]
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Timepoint [1]
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Up to 24 months.
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Secondary outcome [2]
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D3S-001 time to maximum plasma concentration (tmax)
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Assessment method [2]
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Timepoint [2]
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Up to 24 months.
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Secondary outcome [3]
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D3S-001 half-life (t1/2)
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Assessment method [3]
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Timepoint [3]
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Up to 24 months.
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Secondary outcome [4]
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D3S-001 area under the concentration-time curve (AUC)
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Assessment method [4]
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Timepoint [4]
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Up to 24 months.
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Secondary outcome [5]
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Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
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Assessment method [5]
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Timepoint [5]
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Up to 24 months.
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Secondary outcome [6]
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Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
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Assessment method [6]
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Timepoint [6]
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Up to 24 months.
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Secondary outcome [7]
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Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
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Assessment method [7]
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Timepoint [7]
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Up to 24 months.
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Secondary outcome [8]
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Disease Control Rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
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Assessment method [8]
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Timepoint [8]
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Up to 24 months.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/08/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2026
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Actual
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Sample size
Target
352
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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D3 Bio Investigative Site - Sydney
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Recruitment hospital [2]
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D3 Bio Investigative Site - Malvern
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Recruitment hospital [3]
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D3 Bio Investigative Site - Nedlands
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Recruitment postcode(s) [1]
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2109 - Sydney
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Recruitment postcode(s) [2]
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3144 - Malvern
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Michigan
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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China
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State/province [5]
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Beijing
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Country [6]
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China
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State/province [6]
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Guangdong
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Country [7]
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China
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State/province [7]
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Hangzhou
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Country [8]
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China
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State/province [8]
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Heilongjiang
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Country [9]
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China
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State/province [9]
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Hubei
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Country [10]
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China
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State/province [10]
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Jiangxi
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Country [11]
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China
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State/province [11]
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Liaoning
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Country [12]
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China
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State/province [12]
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Shanghai
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Country [13]
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Hong Kong
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State/province [13]
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Sha Tin
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Country [14]
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Korea, Republic of
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State/province [14]
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North Chungcheong
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Country [15]
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Korea, Republic of
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State/province [15]
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Seoul
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
D3 Bio (Wuxi) Co., Ltd
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05410145
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Cheng Chen, MD
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Address
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D3 Bio (Wuxi) Co., Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Medical Director
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Address
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Country
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Phone
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+86 21 61635900
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05410145
Download to PDF