Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Dose escalation - phase 1: S095033 will be administrated at dose of 100 mg,150 mg or 200 mg everyday during a 28-day cycle. The participants will also receive paclitaxel intravenously on D1, D8 and D15 last for 28 days.

Dose expansion - phase 2: Participants with MTAP-deletion and those with MTAP-wild type tumors will be evaluated in separate and independent dose expansion subpopulations.S095033 will be administrated every day during a 28-day cycle at recommended phase 2 dose (RP2D). Paclitaxel given intravenously on D1, D8, and D15 during a 28-day cycle.

Phase 1- dose escalation S095033 ; paclitaxel started at 80 mg/m²,(IV)

Phase 2 - S095033 at RP2D; paclitaxel started at 80 mg/m²,(IV)

Combination (S095033 + paclitaxel)

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)

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)

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.

Including adverse events (AEs) and serious adverse events (SAEs) according to NCI-CTCAE, version 5.0

ADIR, a Servier Group company

Institut de Recherches Internationales Servier

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
S095033 in Combination With Paclitaxel as 2nd- or 3rd-line Treatment in Participants With Advanced or Metastatic ESCC	NCT05312372	Esophageal Squa...	Combination (S0...	18 Years -	Servier
S095033 in Combination With Paclitaxel as 2nd- or 3rd-line Treatment in Participants With Advanced or Metastatic ESCC	NCT05312372	Esophageal Squa...	Combination (S0...	18 Years -	Servier

Spots Global Cancer Trial Database for combination (s095033 + paclitaxel)