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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06188702




Registration number
NCT06188702
Ethics application status
Date submitted
18/12/2023
Date registered
3/01/2024

Titles & IDs
Public title
S095035 in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of the Methylthioadenosine Phosphorylase (MTAP) Gene
Scientific title
A Phase 1, Open-label, Multicenter Clinical Trial of S095035 (MAT2A Inhibitor) in Adult Participants With Advanced or Metastatic Solid Tumors With Homozygous Deletion of MTAP
Secondary ID [1] 0 0
CL1-95035-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
MTAP-deleted Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - S095035

Experimental: Dose Escalation -


Treatment: Drugs: S095035
S095035 will be taken orally once daily in 28-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose limiting toxicities (DLTs) associated with S095035 administration during the first cycle of treatment
Timepoint [1] 0 0
Through cycle 1 (each cycle is 28 days)
Primary outcome [2] 0 0
Total number of adverse events (AEs)
Timepoint [2] 0 0
Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment)
Primary outcome [3] 0 0
Total number of serious adverse events (SAEs)
Timepoint [3] 0 0
Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment)
Secondary outcome [1] 0 0
Area under the concentration-vs-time curve (AUC) from 0 to time of last measurable concentration (AUC0-t)
Timepoint [1] 0 0
Through the last dose of study treatment (approximately 2 years)
Secondary outcome [2] 0 0
AUC from 0 to infinity (AUC0-8)
Timepoint [2] 0 0
Through the last dose of study treatment (approximately 2 years)
Secondary outcome [3] 0 0
AUC over 1 dosing interval at steady state (AUCtau,ss)
Timepoint [3] 0 0
Through the last dose of study treatment (approximately 2 years)
Secondary outcome [4] 0 0
Time to maximum concentration (Tmax)
Timepoint [4] 0 0
Through the last dose of study treatment (approximately 2 years)
Secondary outcome [5] 0 0
Maximum concentration (Cmax)
Timepoint [5] 0 0
Through the last dose of study treatment (approximately 2 years)
Secondary outcome [6] 0 0
Trough concentration (Ctrough)
Timepoint [6] 0 0
Through the last dose of study treatment (approximately 2 years)
Secondary outcome [7] 0 0
Half-life (t½)
Timepoint [7] 0 0
Through the last dose of study treatment (approximately 2 years)
Secondary outcome [8] 0 0
Apparent volume of distribution (Vd/F)
Timepoint [8] 0 0
Through the last dose of study treatment (approximately 2 years)
Secondary outcome [9] 0 0
Apparent clearance (CL/F)
Timepoint [9] 0 0
Through the last dose of study treatment (approximately 2 years)
Secondary outcome [10] 0 0
Change from baseline in plasma concentrations of S-adenosylmethionine (SAM)
Timepoint [10] 0 0
Through the last dose of study treatment (approximately 2 years)
Secondary outcome [11] 0 0
Objective response rate
Timepoint [11] 0 0
Through the end of the study (approximately 2 years)
Secondary outcome [12] 0 0
Clinical benefit rate (CBR)
Timepoint [12] 0 0
Through the end of the study (approximately 2 years)
Secondary outcome [13] 0 0
Duration of response
Timepoint [13] 0 0
Through the end of the study (approximately 2 years)
Secondary outcome [14] 0 0
Time to response
Timepoint [14] 0 0
Through the end of the study (approximately 2 years)

Eligibility
Key inclusion criteria
* Estimated life expectancy =3 months.
* ECOG PS 0-1
* Participants able to comply with highly effective method of birth control requirements.
* Participants with histologically confirmed advanced or metastatic solid tumor's (excluding central nervous system tumors) that have progressed despite at least one prior treatment regimen given for advanced/metastatic disease, and for whom additional effective standard therapy is not available.
* Participants with pre-existing documented MTAP homozygous deletion in their tumor tissue, determined using a next generation sequencing in vitro diagnostic test prior to screening.
* Participants willing to undergo paired fresh biopsy (pre-treatment and post-treatment) procedure. Exceptions may be made for feasibility and safety concerns.
* Adequate organ functions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inability to take an orally administered drug, or medical disorder or prior surgical resection that may affect the absorption of the study drug.
* Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's Medical monitor and investigator agree and document that it should not be exclusionary.
* Known prior severe hypersensitivity to any component of the study drug formulation.
* Major surgery within 4 weeks prior to the first IMP administration or participants who have not recovered from side effects of the surgery.
* Have a known history of Gilbert's syndrome.
* Participants with a known clinically significant cardiovascular disease or condition.
* Participants with thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first IMP administration.
* Active brain metastases.
* Current active liver or biliary disease.
* Participants who have received systemic anticancer treatment or radiotherapy less than 2 weeks before the first dose of S095035. Participants who have not recovered from toxicity of previous anticancer therapy.

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
29/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
27
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [2] 0 0
The Alfred - Prahran
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
3004 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Servier Bio-Innovation LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Institut de Recherches Internationales Servier
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
Address 0 0
Country 0 0
Phone 0 0
+33 1 55 72 60 00
Fax 0 0
Email 0 0
scientificinformation@servier.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

* sponsored by Servier
* with a first patient enrolled as of 1 January 2004 onwards
* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
After Marketing Authorization in EEA or US if the study is used for the approval.
Available to whom?
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicaltrials.servier.com/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06188702