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S095033 in Combination With Paclitaxel as 2nd- or 3rd-line Treatment in Participants With Advanced or Metastatic ESCC | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

S095033 in Combination With Paclitaxel as 2nd- or 3rd-line Treatment in Participants With Advanced or Metastatic ESCC

A Phase 1/2, Open -Label, Multicenter Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antineoplastic Activity of S095033 (MAT2A Inhibitor) in Combination With Paclitaxel in Participants With Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

NCT05312372•Institut de Recherches Internationales Servier

View on ClinicalTrials.gov

Summary

The purpose of this study is to determinate the safety profile, tolerability, pharmacokinetics, and preliminary antineoplastic activity of S095033 in combination with paclitaxel in participants with advanced or metastatic esophageal squamous cell carcinoma (ESCC)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female participant aged ≥ 18 years of age.
•2. Estimated life expectancy ≥12 weeks.
•3. Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
•4. Women of childbearing potential (WOCBP) must use a highly effective method of birth control during study treatment until at least 6 months after the last dose of investigational medicinal product (IMP). In case of use of oral contraception, women should have been stable on the same contraceptive drug (i.e. same active principle) for at least 3 months prior to the first IMP administration.
•5. Male participants with WOCBP partners must use a condom during the study and until at least 6 months after the last dose of IMP. In addition, contraception should be considered for their female partners. Contraceptive measures do not apply if the participant is sterile, vasectomized or sexually abstinent. Sperm donation will not be allowed during the study and for 6 months after the last dose of IMP.
•6. Obtained informed consent (ICF) prior to any study-specific procedure.
•7. Participants with histologically confirmed advanced or metastatic esophageal squamous cell carcinoma that has failed to respond to or has progressed after treatment with standard fluorouracil and platinum-based chemotherapy, or with an anti-PD1 or PD-L1 antibody and not previously treated with a taxane.
•8. Participants who have received one or two prior lines of systemic therapy.
•9. Documented progression on prior line of therapy.
•10. Participants must have at least one measurable lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors.
+7 more criteria

Exclusion Criteria

•1. Non-ability to swallow oral medication.
•2. Pregnant and lactating women.
•3. WOCBP tested positive in a pregnancy test within 7 days prior to the first day of IMP administration.
•4. Participation in another interventional study at the same time or within 2 weeks prior to the first IMP administration.
•5. Participant already enrolled in the study (informed consent signed) and having received at least 1 dose of S095033 and/or paclitaxel.
•6. Known prior severe hypersensitivity to investigational products or any component in their formulations.
•7. Participants who have not recovered from toxicity of previous anticancer therapy, including Grade ≥ 1 non-hematologic toxicity, according to the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) version 5.0, prior to the first IMP administration.
•8. Major surgery within 4 weeks prior to the first IMP administration or participants who have not recovered from side effects of the surgery.
•9. Participants who do not have a biopsy (or sections of it) available or readily obtainable for central confirmation of MTAP status.
•10. Have a history of Gilbert's syndrome.
+11 more criteria

Key Dates

Start Date

May 1, 2025

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

February 17, 2026

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Combination (S095033 + paclitaxel)

DRUG

Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC

NCT07403136

Esophageal Squamous Cell Carcinoma

View study

RECRUITINGPHASE2

Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study

NCT07437898

Esophageal Squamous Cell Carcinoma

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RECRUITING

Registry Platform Gastric/Esophageal Cancer (SAPHIR)

NCT04290806

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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S095033 in Combination With Paclitaxel as 2nd- or 3rd-line Treatment in Participants With Advanced or Metastatic ESCC

Inclusion Criteria

Exclusion Criteria

Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC

Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study

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