Actively Recruiting
S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP
Led by Servier Bio-Innovation LLC · Updated on 2026-04-03
342
Participants Needed
35
Research Sites
391 weeks
Total Duration
On this page
Sponsors
S
Servier Bio-Innovation LLC
Lead Sponsor
I
Institut de Recherches Internationales Servier
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Estimated life expectancy of at least 3 months
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
- Ability to comply with effective birth control methods
- Histologically confirmed advanced or metastatic solid tumors (excluding CNS tumors except IDHwt glioblastoma) with measurable disease per RECIST 1.1 or RANO 2.0 criteria
- Tumor tissue shows pre-existing homozygous MTAP gene deletion confirmed by next generation sequencing test
- Willingness to undergo tumor biopsy procedures as required by phase and tumor type
- Adequate organ function
- Specific requirements for tumor tissue biopsy collection and timing depending on study phase and tumor type
- Progression or recurrence after at least one prior standard systemic therapy for advanced/metastatic disease
- Specific inclusion for various tumor types in phase 2 arms with MTAP deletion
You will not qualify if you...
- Inability to take oral drugs or medical conditions affecting drug absorption
- Active second primary malignancy except certain skin, prostate, cervical, or breast cancers
- Known severe allergy to study drug components
- Major surgery within 4 weeks before study drug start or not recovered from surgery side effects
- Known history of Gilbert's syndrome
- Significant cardiovascular disease or condition
- Thrombosis or history of deep vein thrombosis or pulmonary embolism within 4 weeks before treatment
- Active brain metastases
- Systemic anticancer treatment or radiotherapy within 2 weeks before first dose
- Pregnant or breastfeeding women
- Positive pregnancy test within 7 days before first dose
- Recent history (within 6 months) of gastrointestinal perforation or fistula
- Severe or uncontrolled infections
- Prior treatment with MAT2A or PRMT5 inhibitors
- Medical conditions causing increased photosensitivity
- Known significant eye diseases if receiving combination treatment including retinopathy, glaucoma, macular degeneration, optic neuropathy, or retinal pathology
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
University of California Los Angeles
Los Angeles, California, United States, 90095
Not Yet Recruiting
2
University of California, San Francisco (Ucsf) School of Medicine
San Francisco, California, United States, 94143
Not Yet Recruiting
3
Lake Mary Cancer Center - Florida Cancer Specialists & Research Institute
Lake Mary, Florida, United States, 32746
Terminated
4
Community Health Network
Indianapolis, Indiana, United States, 46250
Actively Recruiting
5
Dana Farber Cancer Institue
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
6
Duke University School of Medicine
Durham, North Carolina, United States, 27710
Not Yet Recruiting
7
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Actively Recruiting
8
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
NEXT Oncology
Austin, Texas, United States, 78758
Actively Recruiting
10
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031
Actively Recruiting
11
The Alfred
Prahran, Victoria, Australia, 3004
Actively Recruiting
12
Townsville University Hospital
Douglas, Australia, 4812
Actively Recruiting
13
Royal Hobart Hospital
Hobart, Australia, 7000
Suspended
14
University Hospital Rigshospitalet
Copenhagen, Denmark, 2100
Not Yet Recruiting
15
Odense Universitets Hospital
Odense, Denmark, 5000
Actively Recruiting
16
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
17
Centre Georges-François Leclerc
Dijon, France, 21079
Actively Recruiting
18
Hôpital de la Timone (Marseille)
Marseille, France, 13385
Actively Recruiting
19
Institut Gustave Roussy
Paris, France, 94805
Actively Recruiting
20
Charite Universitatsmedizin
Berlin, Germany, 13353
Not Yet Recruiting
21
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
22
Med Fakultaet Heidelberg
Heidelberg, Germany, 69120
Not Yet Recruiting
23
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
24
Istituto Europeo Di Oncologia
Milan, Italy, 20141
Not Yet Recruiting
25
A.O.U. Seconda Università Degli Studi Di Napoli
Naples, Italy, 80131
Actively Recruiting
26
Ist. Nazionale Tumori Irccs Fondazione G Pascale
Naples, Italy, 80131
Actively Recruiting
27
Instituto Clinico Humanitas Irccs
Rozzano, Italy, 20098
Actively Recruiting
28
Policlinico G.B. Rossi A.O.U.I. Di Verona
Verona, Italy, 37134
Actively Recruiting
29
Aichi Cancer Center
Aichi, Japan, 4648681
Actively Recruiting
30
National Hospital Organization Shikoku Cancer Center
Ehime, Japan, 7910280
Actively Recruiting
31
The Cancer Institute Hospital of JFCR
Tokyo, Japan, 1358550
Actively Recruiting
32
Next Oncology-Hospital Quironsalud Barcelona
Barcelona, Spain, 8023
Actively Recruiting
33
Hospital Vall D'Hebron
Barcelona, Spain, 8035
Actively Recruiting
34
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
35
Start Madrid Group - Hm Ciocc
Madrid, Spain, 28050
Actively Recruiting
Research Team
I
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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