MTAP-deleted Solid TumorsPhase 1/2NCT06188702
S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP
A Phase 1/2 study testing S095035 and TNG462 in people with MTAP-deleted Solid Tumors, run by Servier Bio-Innovation LLC at 20 sites in 7 countries.
Trial summary
This is a first-in-human Phase 1/2, multicenter, open-label study of S095035 as single-agent, or in combination with TNG462 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MTAP-deleted Solid Tumors
- What is being tested?
- S095035 and TNG462
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 20 sitesin 7 countries
- Study dates
- 29 Apr 2024to 1 May 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 other than IDHwt glioblastoma), with measurable disease as per RECIST 1.1 or RANO 2.0 criteria for participants with IDHwt glioblastoma, that have progressed after at least one prior treatment regimen given for advanced/metastatic disease, and for whom additional effective standard therapy is not available. Patients in China with IDHwt glioblastoma will not be included.
- Participants with pre-existing documented MTAP homozygous gene deletion in their tumor tissue, determined using a next generation sequencing in vitro diagnostic test prior to screening.
- Phase 1 only - Participants (except IDHwt glioblastoma) willing to undergo paired fresh biopsy (pre-treatment and on-treatment) procedure. Exceptions may be made for feasibility and safety concerns. IDHwt glioblastoma must provide archival tissue from most recent surgery or biopsy.
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- Adequate organ functions.
- Phase 2 only - Participants in dose expansion, except those with IDHwt glioblastoma, must provide newly collected tumor biopsies at screening. If not medically feasible archival tissue may be used, provided it was collected within 3 months before study entry and no treatment has been received since the most recent biopsy.
- Phase 2 only - Participants with IDHwt glioblastoma must provide archival tissue from their most recent surgery or biopsy, collected before screening.
- Phase 2 only - Participants in China who are to be considered for enrollment in the single agent dose expansion Arms and who have a pre-existing, documented cyclin-dependent kinase inhibitor 2A (CDKN2A) homozygous gene deletion in their tumor tissue (confirmed by an NGS IVD test), but do not have homozygous MTAP deletion reported, will need to be pre-screened to confirm homozygous MTAP deletion. Pre screening for homozygous MTAP deletion will be conducted using a central NGS IVD test using an archival tumor tissue, preferably the most recent and not older than 3 years.
- Phase 2 Arm 1a only - Participants with histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC with homozygous deletion of MTAP, with measurable disease as per RECIST version 1.1, who have progressed or experienced disease recurrence during or after at least 1 prior line of standard-of-care systemic therapy in the advanced/metastatic setting.
- Phase 2 Arm 1b only - Participants with histologically or cytologically confirmed metastatic or unresectable locally advanced BTC with homozygous deletion of MTAP, who have progressed or experienced disease recurrence during or after at least 1 prior line of standard-of-care systemic therapy in the advanced/metastatic setting.
- Phase 2 Arm 1c only - Participants with histologically or cytologically confirmed metastatic or unresectable locally advanced PDAC with homozygous deletion of MTAP, who have progressed or experienced disease recurrence during or after at least 1 prior line of standard-of-care systemic therapy in the advanced/metastatic setting.
- Phase 2 Arm 1d only - Participants with any other locally advanced or metastatic malignancies with homozygous deletion of MTAP, who have received and progressed of experienced recurrence during or after receiving at least 1 prior line of standard-of-care systemic therapy in the advanced/metastatic setting.
- Phase 2 Arm 2a only - Participants with histologically or cytologically confirmed metastatic or unresectable locally advanced BTC with homozygous deletion of MTAP, who have progressed or experienced disease recurrence during or after receiving at least 1 prior line of standard-of care systemic therapy in the advanced/metastatic setting.
- Phase 2 Arm 2b only - Participants with histologically or cytologically confirmed metastatic or unresectable locally advanced gastroesophageal cancer with homozygous deletion of MTAP, who have progressed or experienced disease recurrence during or after receiving at least 1 prior line of standard-of-care systemic therapy in the advanced/metastatic setting.
- Phase 2 Arm 2c only - Participants with histologically or cytologically confirmed metastatic or unresectable locally advanced PDAC with homozygous deletion of MTAP, who have progressed or experienced disease recurrence during or after receiving at least 1 prior line of standard-of-care systemic therapy in the advanced/metastatic setting.
Who cannot join
- 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 study drug 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.
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- Participants with thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first IMP administration.
- Active brain metastases.
- Participants who have received systemic anticancer treatment or radiotherapy less than 2 weeks before the first dose of study drug
- Pregnant or lactating women.
- Women of childbearing potential who have a positive pregnancy test within 7 days prior to the first day of study drug administration.
- History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to first study drug intake.
- Severe or uncontrolled active acute or chronic infection.
- Participants who have already received a MAT2A or PRMT5 inhibitor.
- A medical condition that results in increased clinically significant photosensitivity (e.g., solar urticaria, lupus erythematosus, etc.).
- Participants who are scheduled to receive the S095035-TNG462 combination, with a known clinically significant ophthalmologic disease, including:
- Prior history of drug-induced or toxic retinopathy or optic neuropathy
- Uncontrolled glaucoma
- Pre-existing macular degeneration
- Ongoing Grade ≥2 retinopathy, optic neuropathy, or optic neuritis
- Other known active retinal pathology
Trial locations and contacts
20 sites in 7 countries.
20 sites in 7 countries
United States5 sites
NEXT Oncology
Austin, Texas, 78758
Community Health Network
Indianapolis, Indiana, 46250
Lake Mary Cancer Center - Florida Cancer Specialists & Research Institute
Lake Mary, Florida, 32746
Taylor Cancer Research Center
Maumee, Ohio, 43537
SCRI Oncology Partners
Nashville, Tennessee, 37203
Australia4 sites
Townsville University Hospital
Douglas, 4812
Royal Hobart Hospital
Hobart, 7000
The Alfred
Prahran, Victoria, 3004
Scientia Clinical Research
Randwick, New South Wales, 2031
Italy3 sites
Istituto Europeo Di Oncologia
Milan, 20141
Instituto Clinico Humanitas Irccs
Rozzano, 20098
Policlinico G.B. Rossi A.O.U.I. Di Verona
Verona, 37134
Japan3 sites
Aichi Cancer Center
Aichi, 4648681
National Hospital Organization Shikoku Cancer Center
Ehime, 7910280
The Cancer Institute Hospital of JFCR
Tokyo, 1358550
France2 sites
Institut Bergonié
Bordeaux, 33076
Centre Georges-François Leclerc
Dijon, 21079
Spain2 sites
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Start Madrid Group - Hm Ciocc
Madrid, 28050
About this study
Official title: A Phase 1/2, Open-label, Multicenter Clinical Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Antineoplastic Activity of S095035 (MAT2A Inhibitor) as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Homozygous Deletion of MTAP
This is a first-in-human Phase 1/2, multicenter, open-label study of S095035 as single-agent, or in combination with TNG462 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. TNG462 is a protein arginine N-methyltransferase 5 [PRMT5] inhibitor.
- Conditions
- MTAP-deleted Solid Tumors
- Being tested
- S095035, TNG462
- Keywords
- MAT2A, MTAP, Solid Tumors, PRMT5, SAM, Synthetic Lethality, MTAP deletion, MAT2A Inhibitor, Advanced Solid Tumors, Biliary Tract Cancer, Non-small Cell Lung Cancer, Pancreatic Adenocarcinoma, Gastroesophageal Cancer
- Medical subject headings
- Biliary Tract Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S095035Drug
S095035 will be taken orally every day in 28-day cycles.
TNG462Drug
TNG462 will be taken orally every day in 28-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Arm 1 - S095035 single-agent dose escalation | Experimental | Not described Receives: Drug: S095035 |
| Phase 1 Arm 2 - S095035-TNG462 combination dose escalation | Experimental | Not described Receives: Drug: S095035; Drug: TNG462 |
| Phase 2 Arm 1a NSCLC - S095035 single-agent dose expansion | Experimental | Non-Small Cell Lung Cancer Receives: Drug: S095035 |
| Phase 2 Arm 1b BTC - S095035 single-agent dose expansion | Experimental | Biliary Tract Cancer Receives: Drug: S095035 |
| Phase 2 Arm 1c PDAC - S095035 single-agent dose expansion | Experimental | Pancreatic Ductal Adenocarcinoma Receives: Drug: S095035 |
| Phase 2 Arm 1d Basket arm - S095035 single-agent dose expansion | Experimental | Not described Receives: Drug: S095035 |
| Phase 2 Arm 2a BTC - S095035-TNG462 combination dose expansion | Experimental | Biliary Tract Cancer Receives: Drug: S095035; Drug: TNG462 |
| Phase 2 Arm 2b Gastroesophageal - S095035-TNG462 combination dose expansion | Experimental | Not described Receives: Drug: S095035; Drug: TNG462 |
| Phase 2 Arm 2c PDAC - S095035-TNG462 combination dose expansion | Experimental | Pancreatic Ductal Adenocarcinoma Receives: Drug: S095035; Drug: TNG462 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities (DLTs)
Phase 1 only
Measured: Through cycle 1 (each cycle is 28 days)
Total number of adverse events (AEs)
Phase 1 only
Measured: Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years
Total number of serious adverse events (SAEs)
Phase 1 only
Measured: Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years
Objective response rate (ORR)
Phase 2 only; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment and by blinded independent central review (BICR)
Measured: Through the end of the study (approximately 5 years)
Secondary outcomes (22)
Area under the concentration-vs-time curve (AUC) from 0 to time of last measurable concentration (AUC0-t)
Phase 1 and 2
Measured: Through the last dose of study treatment (approximately 5 years)
AUC from 0 to infinity (AUC0-∞)
Phase 1 and 2
Measured: Through the last dose of study treatment (approximately 5 years)
AUC over 1 dosing interval at steady state (AUCtau,ss)
Phase 1 and 2
Measured: Through the last dose of study treatment (approximately 5 years)
Time to maximum concentration (Tmax)
Phase 1 and 2
Measured: Through the last dose of study treatment (approximately 5 years)
Maximum concentration (Cmax)
Phase 1 and 2
Measured: Through the last dose of study treatment (approximately 5 years)
Trough concentration (Ctrough)
Phase 1 and 2
Measured: Through the last dose of study treatment (approximately 5 years)
Half-life (t½)
Phase 1 and 2
Measured: Through the last dose of study treatment (approximately 5 years)
Apparent volume of distribution (Vd/F)
Phase 1 and 2
Measured: Through the last dose of study treatment (approximately 5 years)
Apparent clearance (CL/F)
Phase 1 and 2
Measured: Through the last dose of study treatment (approximately 5 years)
Change from baseline in plasma concentrations of S-adenosylmethionine (SAM) and/or tumor symmetric dimethylarginine (SDMA) residues during treatment
Phase 1 only
Measured: Through the last dose of study treatment (approximately 5 years)
Objective response rate (ORR)
Phase 1 only; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment
Measured: Through the end of the study (approximately 5 years)
Best overall response (BOR)
Phase 1 and 2; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment for Phase 1 and 2, and by BICR only for Phase 2.
Measured: Through the end of the study (approximately 5 years)
Clinical benefit rate (CBR)
Phase 1 and 2; CBR=complete response [CR]+partial response [PR]+stable disease [SD] ) ≥6 months, Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment for Phase 1 and 2, and by BICR only for Phase 2
Measured: Through the end of the study (approximately 5 years)
Duration of response (DOR)
Phase 1 and 2; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment for Phase 1 and 2, and by BICR only for Phase 2. 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.
Measured: Through the end of the study (approximately 5 years)
Time to response (TTR)
Phase 1 and 2; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment for Phase 1 and 2, and by BICR only for Phase 2. The time from the date of randomization to date of first documented confirmed complete response (CR) or confirmed partial response (PR).
Measured: Through the end of the study (approximately 5 years)
Progression-free Survival (PFS)
Phase 2 Only; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as assessed by investigator and by BICR
Measured: Through the end of the study (approximately 5 years)
Overall Survival (OS)
Phase 2 Only; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as assessed by investigator and by BICR
Measured: Through the end of the study (approximately 5 years)
Total number of adverse events (AEs)
Phase 2 Only
Measured: Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years
Total number of serious adverse events (SAEs)
Phase 2 Only
Measured: Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years
Number of dose interruptions
Phase 2 Only
Measured: Through the last dose of study treatment (approximately 5 years)
Number of dose reductions
Phase 2 Only
Measured: Through the last dose of study treatment (approximately 5 years)
Dose intensity
Phase 2 Only
Measured: Through the last dose of study treatment (approximately 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start29 Apr 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MTAP-deleted Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Bio-Innovation LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut de Recherches Internationales Servier, Tango Therapeutics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188702
- Sponsor's protocol ID
- CL1-95035-001
- Other IDs
- 2025-521249-25-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 18 Dec 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-label, Multicenter Clinical Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Antineoplastic Activity of S095035 (MAT2A Inhibitor) as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Homozygous Deletion of MTAP
- ClinicalTrials.gov ID
- NCT06188702
- Acronym / sponsor ID
- CL1-95035-001
- Conditions
- MTAP-deleted Solid Tumors
- Keywords
- MAT2A, MTAP, Solid Tumors, PRMT5, SAM, Synthetic Lethality, MTAP deletion, MAT2A Inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Servier Bio-Innovation LLCIndustry (pharma, biotech, devices)
- Collaborators
- Institut de Recherches Internationales Servier, Tango Therapeutics, Inc.
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human Phase 1/2, multicenter, open-label study of S095035 as single-agent, or in combination with TNG462 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. TNG462 is a protein arginine N-methyltransferase 5 [PRMT5] inhibitor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Arm 1 - S095035 single-agent dose escalation | Experimental | Drug: S095035 |
| Phase 1 Arm 2 - S095035-TNG462 combination dose escalation | Experimental | Drug: S095035, Drug: TNG462 |
| Phase 2 Arm 1a NSCLC - S095035 single-agent dose expansion | Experimental | Drug: S095035Non-Small Cell Lung Cancer |
| Phase 2 Arm 1b BTC - S095035 single-agent dose expansion | Experimental | Drug: S095035Biliary Tract Cancer |
| Phase 2 Arm 1c PDAC - S095035 single-agent dose expansion | Experimental | Drug: S095035Pancreatic Ductal Adenocarcinoma |
| Phase 2 Arm 1d Basket arm - S095035 single-agent dose expansion | Experimental | Drug: S095035 |
| Phase 2 Arm 2a BTC - S095035-TNG462 combination dose expansion | Experimental | Drug: S095035, Drug: TNG462Biliary Tract Cancer |
| Phase 2 Arm 2b Gastroesophageal - S095035-TNG462 combination dose expansion | Experimental | Drug: S095035, Drug: TNG462 |
| Phase 2 Arm 2c PDAC - S095035-TNG462 combination dose expansion | Experimental | Drug: S095035, Drug: TNG462Pancreatic Ductal Adenocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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 other than IDHwt glioblastoma), with measurable disease as per RECIST 1.1 or RANO 2.0 criteria for participants with IDHwt glioblastoma, that have progressed after at least one prior treatment regimen given for advanced/metastatic disease, and for whom additional effective standard therapy is not available. Patients in China with IDHwt glioblastoma will not be included.
- Participants with pre-existing documented MTAP homozygous gene deletion in their tumor tissue, determined using a next generation sequencing in vitro diagnostic test prior to screening.
Key exclusion criteria (21 listed)
- 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 study drug administration or participants who have not recovered from side effects of the surgery.
- Have a known history of Gilbert's syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S095035S095035 will be taken orally every day in 28-day cycles. | Drug | Phase 1 Arm 1 - S095035 single-agent dose escalation, Phase 1 Arm 2 - S095035-TNG462 combination dose escalation, Phase 2 Arm 1a NSCLC - S095035 single-agent dose expansion, Phase 2 Arm 1b BTC - S095035 single-agent dose expansion, Phase 2 Arm 1c PDAC - S095035 single-agent dose expansion, Phase 2 Arm 1d Basket arm - S095035 single-agent dose expansion, Phase 2 Arm 2a BTC - S095035-TNG462 combination dose expansion, Phase 2 Arm 2b Gastroesophageal - S095035-TNG462 combination dose expansion, Phase 2 Arm 2c PDAC - S095035-TNG462 combination dose expansion |
| TNG462TNG462 will be taken orally every day in 28-day cycles. | Drug | Phase 1 Arm 2 - S095035-TNG462 combination dose escalation, Phase 2 Arm 2a BTC - S095035-TNG462 combination dose expansion, Phase 2 Arm 2b Gastroesophageal - S095035-TNG462 combination dose expansion, Phase 2 Arm 2c PDAC - S095035-TNG462 combination dose expansion |
Primary outcome
Dose limiting toxicities (DLTs)
Time frame: Through cycle 1 (each cycle is 28 days)
Phase 1 only
Total number of adverse events (AEs)
Time frame: Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years
Phase 1 only
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) approximately 5 years
Phase 1 only
Objective response rate (ORR)
Time frame: Through the end of the study (approximately 5 years)
Phase 2 only; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment and by blinded independent central review (BICR)
22 secondary outcomes
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 5 years)
AUC from 0 to infinity (AUC0-∞)
Time frame: Through the last dose of study treatment (approximately 5 years)
AUC over 1 dosing interval at steady state (AUCtau,ss)
Time frame: Through the last dose of study treatment (approximately 5 years)
Time to maximum concentration (Tmax)
Time frame: Through the last dose of study treatment (approximately 5 years)
Maximum concentration (Cmax)
Time frame: Through the last dose of study treatment (approximately 5 years)
Trough concentration (Ctrough)
Time frame: Through the last dose of study treatment (approximately 5 years)
Half-life (t½)
Time frame: Through the last dose of study treatment (approximately 5 years)
Apparent volume of distribution (Vd/F)
Time frame: Through the last dose of study treatment (approximately 5 years)
Apparent clearance (CL/F)
Time frame: Through the last dose of study treatment (approximately 5 years)
Change from baseline in plasma concentrations of S-adenosylmethionine (SAM) and/or tumor symmetric dimethylarginine (SDMA) residues during treatment
Time frame: Through the last dose of study treatment (approximately 5 years)
Objective response rate (ORR)
Time frame: Through the end of the study (approximately 5 years)
Best overall response (BOR)
Time frame: Through the end of the study (approximately 5 years)
Clinical benefit rate (CBR)
Time frame: Through the end of the study (approximately 5 years)
Duration of response (DOR)
Time frame: Through the end of the study (approximately 5 years)
Time to response (TTR)
Time frame: Through the end of the study (approximately 5 years)
Progression-free Survival (PFS)
Time frame: Through the end of the study (approximately 5 years)
Overall Survival (OS)
Time frame: Through the end of the study (approximately 5 years)
Total number of adverse events (AEs)
Time frame: Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years
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) approximately 5 years
Number of dose interruptions
Time frame: Through the last dose of study treatment (approximately 5 years)
Number of dose reductions
Time frame: Through the last dose of study treatment (approximately 5 years)
Dose intensity
Time frame: Through the last dose of study treatment (approximately 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing S095035 and TNG462 in people with MTAP-deleted Solid Tumors, run by Servier Bio-Innovation LLC at 20 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Australia, Italy, Japan, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicities (DLTs) (time frame: Through cycle 1 (each cycle is 28 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.