S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP
NCT ID: NCT06188702
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
342 participants
INTERVENTIONAL
2024-04-29
2031-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sorafenib in Treating Patients With Metastatic or Unresectable Solid Tumors, Multiple Myeloma, or Non-Hodgkin's Lymphoma With or Without Impaired Liver or Kidney Function
NCT00118170
Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)
NCT05638295
Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion
NCT05245500
Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System
NCT07042295
Sorafenib Tosylate, Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With High-Risk Stage IIB-IV Soft Tissue Sarcoma
NCT02050919
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase 1 Arm 1 - S095035 single-agent dose escalation
S095035
S095035 will be taken orally every day in 28-day cycles.
Phase 1 Arm 2 - S095035-TNG462 combination dose escalation
S095035
S095035 will be taken orally every day in 28-day cycles.
TNG462
TNG462 will be taken orally every day in 28-day cycles.
Phase 2 Arm 1a NSCLC - S095035 single-agent dose expansion
Non-Small Cell Lung Cancer
S095035
S095035 will be taken orally every day in 28-day cycles.
Phase 2 Arm 1b BTC - S095035 single-agent dose expansion
Biliary Tract Cancer
S095035
S095035 will be taken orally every day in 28-day cycles.
Phase 2 Arm 1c PDAC - S095035 single-agent dose expansion
Pancreatic Ductal Adenocarcinoma
S095035
S095035 will be taken orally every day in 28-day cycles.
Phase 2 Arm 1d Basket arm - S095035 single-agent dose expansion
S095035
S095035 will be taken orally every day in 28-day cycles.
Phase 2 Arm 2a BTC - S095035-TNG462 combination dose expansion
Biliary Tract Cancer
S095035
S095035 will be taken orally every day in 28-day cycles.
TNG462
TNG462 will be taken orally every day in 28-day cycles.
Phase 2 Arm 2b Gastroesophageal - S095035-TNG462 combination dose expansion
S095035
S095035 will be taken orally every day in 28-day cycles.
TNG462
TNG462 will be taken orally every day in 28-day cycles.
Phase 2 Arm 2c PDAC - S095035-TNG462 combination dose expansion
Pancreatic Ductal Adenocarcinoma
S095035
S095035 will be taken orally every day in 28-day cycles.
TNG462
TNG462 will be taken orally every day in 28-day cycles.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
S095035
S095035 will be taken orally every day in 28-day cycles.
TNG462
TNG462 will be taken orally every day in 28-day cycles.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut de Recherches Internationales Servier
OTHER
Tango Therapeutics, Inc.
INDUSTRY
Servier Bio-Innovation LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California Los Angeles
Los Angeles, California, United States
University of California, San Francisco (Ucsf) School of Medicine
San Francisco, California, United States
Lake Mary Cancer Center - Florida Cancer Specialists & Research Institute
Lake Mary, Florida, United States
Community Health Network
Indianapolis, Indiana, United States
Dana Farber Cancer Institue
Boston, Massachusetts, United States
Duke University School of Medicine
Durham, North Carolina, United States
Taylor Cancer Research Center
Maumee, Ohio, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
NEXT Oncology
Austin, Texas, United States
Scientia Clinical Research
Randwick, New South Wales, Australia
The Alfred
Prahran, Victoria, Australia
Townsville University Hospital
Douglas, , Australia
Royal Hobart Hospital
Hobart, , Australia
University Hospital Rigshospitalet
Copenhagen, , Denmark
Odense Universitets Hospital
Odense, , Denmark
Institut Bergonié
Bordeaux, , France
Centre Georges-François Leclerc
Dijon, , France
Charite Universitatsmedizin
Berlin, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Med Fakultaet Heidelberg
Heidelberg, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Istituto Europeo Di Oncologia
Milan, , Italy
A.O.U. Seconda Università Degli Studi Di Napoli
Napoli, , Italy
Ist. Nazionale Tumori Irccs Fondazione G Pascale
Napoli, , Italy
Instituto Clinico Humanitas Irccs
Rozzano, , Italy
Policlinico G.B. Rossi A.O.U.I. Di Verona
Verona, , Italy
Aichi Cancer Center
Aichi, , Japan
National Hospital Organization Shikoku Cancer Center
Ehime, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Next Oncology-Hospital Quironsalud Barcelona
Barcelona, , Spain
Hospital Vall D'Hebron
Barcelona, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Start Madrid Group - Hm Ciocc
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
Role: CONTACT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-521249-25-00
Identifier Type: CTIS
Identifier Source: secondary_id
CL1-95035-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.