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S095035 in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of the Methylthioadenosine Phosphorylase (MTAP) Gene

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ClinicalTrials.gov Identifier: NCT06188702
Recruitment Status : Recruiting
First Posted : January 3, 2024
Last Update Posted : May 2, 2024
Sponsor:
Collaborator:
Institut de Recherches Internationales Servier
Information provided by (Responsible Party):
Servier ( Servier Bio-Innovation LLC )

Study Description
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Brief Summary:
This is a first-in-human Phase 1, multicenter, open-label dose escalation study of S095035 in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP who have failed to respond to or have progressed after at least 1 prior treatment regimen, and for whom additional effective standard treatment is not available. S095035 is an oral methionine adenosyltransferase 2A [MAT2A] inhibitor.

Condition or disease Intervention/treatment Phase
MTAP-deleted Solid Tumors Drug: S095035 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 29, 2024
Estimated Primary Completion Date : May 1, 2026
Estimated Study Completion Date : May 1, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation Drug: S095035
S095035 will be taken orally once daily in 28-day cycle.


Outcome Measures
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Primary Outcome Measures :
  1. Dose limiting toxicities (DLTs) associated with S095035 administration during the first cycle of treatment [ Time Frame: Through cycle 1 (each cycle is 28 days) ]
  2. Total number of adverse events (AEs) [ Time Frame: Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) ]
  3. Total number of serious adverse events (SAEs) [ Time Frame: Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) ]

Secondary Outcome Measures :
  1. Area under the concentration-vs-time curve (AUC) from 0 to time of last measurable concentration (AUC0-t) [ Time Frame: Through the last dose of study treatment (approximately 2 years) ]
  2. AUC from 0 to infinity (AUC0-∞) [ Time Frame: Through the last dose of study treatment (approximately 2 years) ]
  3. AUC over 1 dosing interval at steady state (AUCtau,ss) [ Time Frame: Through the last dose of study treatment (approximately 2 years) ]
  4. Time to maximum concentration (Tmax) [ Time Frame: Through the last dose of study treatment (approximately 2 years) ]
  5. Maximum concentration (Cmax) [ Time Frame: Through the last dose of study treatment (approximately 2 years) ]
  6. Trough concentration (Ctrough) [ Time Frame: Through the last dose of study treatment (approximately 2 years) ]
  7. Half-life (t½) [ Time Frame: Through the last dose of study treatment (approximately 2 years) ]
  8. Apparent volume of distribution (Vd/F) [ Time Frame: Through the last dose of study treatment (approximately 2 years) ]
  9. Apparent clearance (CL/F) [ Time Frame: Through the last dose of study treatment (approximately 2 years) ]
  10. Change from baseline in plasma concentrations of S-adenosylmethionine (SAM) [ Time Frame: Through the last dose of study treatment (approximately 2 years) ]
  11. Objective response rate [ Time Frame: Through the end of the study (approximately 2 years) ]
    Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per the investigator's assessment

  12. Clinical benefit rate (CBR) [ Time Frame: Through the end of the study (approximately 2 years) ]
    CBR=complete response [CR]+partial response [PR]+stable disease [SD] ) ≥6 months, Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per the investigator's assessment

  13. Duration of response [ Time Frame: Through the end of the study (approximately 2 years) ]
    Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per the investigator's assessment. The time from date of first documented confirmed CR or confirmed PR to date of first documented disease progression or death due to any cause.

  14. Time to response [ Time Frame: Through the end of the study (approximately 2 years) ]
    Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per the investigator's assessment. The time from the date of randomization to date of first documented confirmed complete response (CR) or confirmed partial response (PR).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06188702


Contacts
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Contact: Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department +33 1 55 72 60 00 scientificinformation@servier.com

Locations
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United States, Florida
Lake Mary Cancer Center - Florida Cancer Specialists & Research Institute Not yet recruiting
Lake Mary, Florida, United States, 32746
United States, Tennessee
SCRI Oncology Partners Not yet recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
NEXT Oncology Not yet recruiting
Austin, Texas, United States, 78758
Australia, New South Wales
Scientia Clinical Research Recruiting
Randwick, New South Wales, Australia, 2031
Australia, Victoria
The Alfred Not yet recruiting
Prahran, Victoria, Australia, 3004
Sponsors and Collaborators
Servier Bio-Innovation LLC
Institut de Recherches Internationales Servier
More Information
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Responsible Party: Servier Bio-Innovation LLC
ClinicalTrials.gov Identifier: NCT06188702    
Other Study ID Numbers: CL1-95035-001
First Posted: January 3, 2024    Key Record Dates
Last Update Posted: May 2, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After Marketing Authorization in EEA or US if the study is used for the approval.
Access Criteria: 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.
URL: http://clinicaltrials.servier.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Servier ( Servier Bio-Innovation LLC ):
MAT2A
MTAP
Solid Tumors
PRMT5
SAM
 Synthetic Lethality
MTAP deletion
MAT2A Inhibitor
Advanced Solid Tumors
Additional relevant MeSH terms:
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Neoplasms