Esophageal Squamous Cell CarcinomaPhase 1/2NCT05312372
S095033 in Combination With Paclitaxel as 2nd- or 3rd-line Treatment in Participants With Advanced or Metastatic ESCC
A Phase 1/2 study testing Combination (S095033 + paclitaxel) in people with Esophageal Squamous Cell Carcinoma, run by Institut de Recherches Internationales Servier.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Combination (S095033 + paclitaxel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Jun 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Male or female participant aged ≥ 18 years of age.
- Estimated life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2.
- 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.
- 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.
- Obtained informed consent (ICF) prior to any study-specific procedure.
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- 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.
- Participants who have received one or two prior lines of systemic therapy.
- Documented progression on prior line of therapy.
- Participants must have at least one measurable lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors.
- For participants with MTAP deletion, evidence of homozygous loss of MTAP in archival or fresh tumor tissue.
- For participants with MTAP wild type, evidence of the presence of MTAP in archival or fresh tumor tissue.
- Adequate hematological function based on the last assessment performed within 7 days prior to the first IMP administration.
- Adequate coagulation function for all participants. For participants receiving anti- coagulant therapy (except platelet anti-aggregants), the adequate therapeutic levels of INR should be confirmed.
- Adequate renal function based on the last assessment performed within 7 days prior to the first IMP administration.
- Adequate hepatic function based on the last assessment performed within 7 days prior to the first IMP administration.
- Serum albumin ≥ 3 g/dL.
Who cannot join
- Non-ability to swallow oral medication.
- Pregnant and lactating women.
- WOCBP tested positive in a pregnancy test within 7 days prior to the first day of IMP administration.
- Participation in another interventional study at the same time or within 2 weeks prior to the first IMP administration.
- Participant already enrolled in the study (informed consent signed) and having received at least 1 dose of S095033 and/or paclitaxel.
- Known prior severe hypersensitivity to investigational products or any component in their formulations.
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- 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.
- Major surgery within 4 weeks prior to the first IMP administration or participants who have not recovered from side effects of the surgery.
- Participants who do not have a biopsy (or sections of it) available or readily obtainable for central confirmation of MTAP status.
- Have a history of Gilbert's syndrome.
- History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization.
- Apparent tumor invasion into organs located adjacent to the esophageal disease site (e.g. aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator.
- Have a degenerative retinal disease that could increase the risk for visual loss with S095033 or confound the interpretation of retinal changes in the course of S095033 treatment.
- Severe or uncontrolled active acute or chronic infection.
- 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.
- Symptoms suggesting central nervous system involvement, including symptomatic metastasis, for which treatment is required.
- Participants who have received systemic anticancer treatment or radiotherapy less than 2 weeks before the first dose of S095033.
- Any clinically significant medical condition (e.g. organ dysfunction) or laboratory abnormality likely to jeopardize the participant's safety or to interfere with the conduct of the study, in the investigator's opinion.
- Any contraindication to the use of paclitaxel as per standard labelling and local guidance.
- For prior and forbidden concomitant medication.
About this study
Official title: 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)
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)
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Combination (S095033 + paclitaxel)
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination (S095033 + paclitaxel)Drug
Phase 1- dose escalation S095033 ; paclitaxel started at 80 mg/m²,(IV)
Phase 2 - S095033 at RP2D; paclitaxel started at 80 mg/m²,(IV)
| Study group | Role | What they receive |
|---|---|---|
| S095033 in combination with paclitaxel | Experimental | 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. Receives: Drug: Combination (S095033 + paclitaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs) associated with S095033 administration during the first cycle of treatment (Phase 1)
DLTs observed during a 28-day period
Measured: At the end of Cycle 1 (each cycle is 28 days)
Adverse events (AEs) (Phase 1)
Including adverse events (AEs) and serious adverse events (SAEs) according to NCI-CTCAE, version 5.0
Measured: up to 28 days after the last IMP administration (for all AEs) or up to 4 years (for all SAE related to the research)
Changes in laboratory assessments (hematology and blood biochemistry) (Phase 1)
Measured: Screening, Day1(D1) D8 D15 and D22 from Cycle 1 to Cycle 4 (each cycle is 28 days),D1 and D15 from Cycle 5 (each cycle is 28 days) up to 28 days after the last IMP administration
Changes in physical examination and in performance status (ECOG) (Phase 1)
Measured: Screening, D1 and D15 of Cycle 1, D1 for all the remaining cycles up to 28 days after the last IMP administration
Abnormalities in 12-lead ECG parameters (Phase 1)
Measured: Screening, D1 and D2 of Cycle 1, D1 for all the following cycles until withdrawal visit (within 5 days after the last IMP administration)
Changes in vital signs: SBP, DBP, respiratory rate and temperature (Phase 1)
Measured: Screening, D1 D8 D15 and D22 of Cycle 1, D1 for all the following cycles up to 28 days after the last IMP administration
Objective response per central review of antitumor activity (using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) (Phase 2)
Measured: Screening,and after the completion of every 2 cycles until disease progression
Secondary outcomes (20)
The PK (pharmacokinetic) profile of S095033 and paclitaxel plasma concentration : Area under the plasma concentration-time curve (AUC) (Phase 1 and phase 2)
Measured: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration
The PK profile of S095033 and paclitaxel plasma concentration : Time to maximum concentration (Tmax) (Phase 1 and phase 2)
Measured: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration
The PK profile of S095033 and paclitaxel plasma concentration : Maximum plasma concentration (Cmax) (Phase 1 and phase 2)
Measured: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration
The PK profile of S095033 and paclitaxel plasma concentration : Trough concentation (Ctrough) (Phase 1 and phase 2)
Measured: : D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration
The PK profile of S095033 and paclitaxel plasma concentration : Half time (t1/2) (Phase 1 and phase 2)
Measured: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration
The PK profile of S095033 and paclitaxel plasma concentration :apparent volume of distribution (Vd/F) (Phase 1 and phase 2)
Measured: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration
The PK profile of S095033 and paclitaxel plasma concentration :apparent clearance (CL/F) (Phase 1 and phase 2)
Measured: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration
Changes in plasma concentration of S-adenosylmethionine (SAM) and methionine (Phase 1 and phase 2)
Measured: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until withdrawal visit (within 5 days after the last IMP administration)
Objective response per Investigator assessment of antitumor activity (using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) (Phase 1 and phase 2)
Measured: Screening, and after the completion of every 2 cycles until disease progression
Clinical Benefit (CB) (Phase 1 and phase 2)
Measured: Screening, and after the completion of every 2 cycles until disease progression
Duration of response (DOR) (Phase 1 and phase 2)
Measured: Screening, and after the completion of every 2 cycles until disease progression
Progression-free survival (PFS) (Phase 1 and phase 2)
Measured: Screening, and after the completion of every 2 cycles until disease progression
Overall survival (OS) (Phase 1 and phase 2)
Measured: Screening, and after the completion of every 2 cycles up to 6 months after the last IMP administration
Time To Response (TTR) (Phase 1 and phase 2)
Measured: Screening, and after the completion of every 2 cycles until the first occurrence of a complete response (CR) or partial response (PR), whichever occurs first
Adverse events (AEs) (Phase 2)
Including adverse events (AEs) and serious adverse events (SAEs) according to NCI-CTCAE, version 5.0
Measured: up to 28 days after the last IMP administration (for all AEs) or up to 4 years (for all SAE related to the research)
DLT associated with S095033 administration during the first cycle of treatment (Phase 2)
DLTs observed during a 28-day period
Measured: At the end of Cycle1 (each cycle is 28 days)
Changes in laboratory assessments (hematology and blood biochemistry ) (Phase 2)
Measured: Screening, D1, D8 D15 and D22 from Cycle 1 to Cycle 4 (each cycle is 28 days), D1 and D15 from Cycle 5 (each cycle is 28 days) up to 28 days after the last IMP administration
Changes in physical examination and in performance status (ECOG) (Phase 2)
Measured: Screening, D1 and D15 of Cycle 1, D1 for all the remaining cycles up to 28 days after the last IMP administration
Abnormalities in 12-lead ECG parameters (Phase 2)
Measured: Screening, D1 and D2 of Cycle 1, D1 for all the following cycles until withdrawal visit (within 5 days after the last IMP administration)
Changes in vital signs : SBP, DBP, respiratory rate and temperature (Phase 2)
Measured: Screening, D1 D8 D15 and D22 of Cycle 1, D1 for all the following cycles up to 28 days after the last IMP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study startMay 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: Strategic development reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312372
- Sponsor's protocol ID
- CL1-95033-002
- Other IDs
- 2022-000250-29
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05312372
- Acronym / sponsor ID
- CL1-95033-002
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic development reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Study start
- May 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 5 Apr 2022 (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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S095033 in combination with paclitaxel | Experimental | Drug: Combination (S095033 + paclitaxel)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female participant aged ≥ 18 years of age.
- Estimated life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2.
- 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.
- 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.
Key exclusion criteria (21 listed)
- Non-ability to swallow oral medication.
- Pregnant and lactating women.
- WOCBP tested positive in a pregnancy test within 7 days prior to the first day of IMP administration.
- Participation in another interventional study at the same time or within 2 weeks prior to the first IMP administration.
- Participant already enrolled in the study (informed consent signed) and having received at least 1 dose of S095033 and/or paclitaxel.
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 |
|---|---|---|
| Combination (S095033 + paclitaxel)Phase 1- dose escalation S095033 ; paclitaxel started at 80 mg/m²,(IV) Phase 2 - S095033 at RP2D; paclitaxel started at 80 mg/m²,(IV) | Drug | S095033 in combination with paclitaxel |
Primary outcome
Dose-limiting toxicities (DLTs) associated with S095033 administration during the first cycle of treatment (Phase 1)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
DLTs observed during a 28-day period
Adverse events (AEs) (Phase 1)
Time frame: up to 28 days after the last IMP administration (for all AEs) or up to 4 years (for all SAE related to the research)
Including adverse events (AEs) and serious adverse events (SAEs) according to NCI-CTCAE, version 5.0
Changes in laboratory assessments (hematology and blood biochemistry) (Phase 1)
Time frame: Screening, Day1(D1) D8 D15 and D22 from Cycle 1 to Cycle 4 (each cycle is 28 days),D1 and D15 from Cycle 5 (each cycle is 28 days) up to 28 days after the last IMP administration
Changes in physical examination and in performance status (ECOG) (Phase 1)
Time frame: Screening, D1 and D15 of Cycle 1, D1 for all the remaining cycles up to 28 days after the last IMP administration
Abnormalities in 12-lead ECG parameters (Phase 1)
Time frame: Screening, D1 and D2 of Cycle 1, D1 for all the following cycles until withdrawal visit (within 5 days after the last IMP administration)
Changes in vital signs: SBP, DBP, respiratory rate and temperature (Phase 1)
Time frame: Screening, D1 D8 D15 and D22 of Cycle 1, D1 for all the following cycles up to 28 days after the last IMP administration
Objective response per central review of antitumor activity (using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) (Phase 2)
Time frame: Screening,and after the completion of every 2 cycles until disease progression
20 secondary outcomes
The PK (pharmacokinetic) profile of S095033 and paclitaxel plasma concentration : Area under the plasma concentration-time curve (AUC) (Phase 1 and phase 2)
Time frame: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration
The PK profile of S095033 and paclitaxel plasma concentration : Time to maximum concentration (Tmax) (Phase 1 and phase 2)
Time frame: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration
The PK profile of S095033 and paclitaxel plasma concentration : Maximum plasma concentration (Cmax) (Phase 1 and phase 2)
Time frame: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration
The PK profile of S095033 and paclitaxel plasma concentration : Trough concentation (Ctrough) (Phase 1 and phase 2)
Time frame: : D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration
The PK profile of S095033 and paclitaxel plasma concentration : Half time (t1/2) (Phase 1 and phase 2)
Time frame: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration
The PK profile of S095033 and paclitaxel plasma concentration :apparent volume of distribution (Vd/F) (Phase 1 and phase 2)
Time frame: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration
The PK profile of S095033 and paclitaxel plasma concentration :apparent clearance (CL/F) (Phase 1 and phase 2)
Time frame: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until the last IMP administration
Changes in plasma concentration of S-adenosylmethionine (SAM) and methionine (Phase 1 and phase 2)
Time frame: D1 D2 D8 D15 D28 of Cycle 1, D1 for the following cycles until withdrawal visit (within 5 days after the last IMP administration)
Objective response per Investigator assessment of antitumor activity (using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) (Phase 1 and phase 2)
Time frame: Screening, and after the completion of every 2 cycles until disease progression
Clinical Benefit (CB) (Phase 1 and phase 2)
Time frame: Screening, and after the completion of every 2 cycles until disease progression
Duration of response (DOR) (Phase 1 and phase 2)
Time frame: Screening, and after the completion of every 2 cycles until disease progression
Progression-free survival (PFS) (Phase 1 and phase 2)
Time frame: Screening, and after the completion of every 2 cycles until disease progression
Overall survival (OS) (Phase 1 and phase 2)
Time frame: Screening, and after the completion of every 2 cycles up to 6 months after the last IMP administration
Time To Response (TTR) (Phase 1 and phase 2)
Time frame: Screening, and after the completion of every 2 cycles until the first occurrence of a complete response (CR) or partial response (PR), whichever occurs first
Adverse events (AEs) (Phase 2)
Time frame: up to 28 days after the last IMP administration (for all AEs) or up to 4 years (for all SAE related to the research)
DLT associated with S095033 administration during the first cycle of treatment (Phase 2)
Time frame: At the end of Cycle1 (each cycle is 28 days)
Changes in laboratory assessments (hematology and blood biochemistry ) (Phase 2)
Time frame: Screening, D1, D8 D15 and D22 from Cycle 1 to Cycle 4 (each cycle is 28 days), D1 and D15 from Cycle 5 (each cycle is 28 days) up to 28 days after the last IMP administration
Changes in physical examination and in performance status (ECOG) (Phase 2)
Time frame: Screening, D1 and D15 of Cycle 1, D1 for all the remaining cycles up to 28 days after the last IMP administration
Abnormalities in 12-lead ECG parameters (Phase 2)
Time frame: Screening, D1 and D2 of Cycle 1, D1 for all the following cycles until withdrawal visit (within 5 days after the last IMP administration)
Changes in vital signs : SBP, DBP, respiratory rate and temperature (Phase 2)
Time frame: Screening, D1 D8 D15 and D22 of Cycle 1, D1 for all the following cycles up to 28 days after the last IMP administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Combination (S095033 + paclitaxel) in people with Esophageal Squamous Cell Carcinoma, run by Institut de Recherches Internationales Servier.
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: withdrawn, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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) associated with S095033 administration during the first cycle of treatment (Phase 1) (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 7 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 17 Feb 2026.