S095033 in Combination With Paclitaxel as 2nd- or 3rd-line Treatment in Participants With Advance… (NCT05312372) | Clinical Trial Compass
WithdrawnPhase 1/2
S095033 in Combination With Paclitaxel as 2nd- or 3rd-line Treatment in Participants With Advanced or Metastatic ESCC
Stopped: Strategic development reasons
0Started 2025-05
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. Non-ability to swallow oral medication.
What they're measuring
1
Dose-limiting toxicities (DLTs) associated with S095033 administration during the first cycle of treatment (Phase 1)
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
2
Adverse events (AEs) (Phase 1)
Timeframe: up to 28 days after the last IMP administration (for all AEs) or up to 4 years (for all SAE related to the research)
3
Changes in laboratory assessments (hematology and blood biochemistry) (Phase 1)
Timeframe: 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
4
Changes in physical examination and in performance status (ECOG) (Phase 1)
Timeframe: Screening, D1 and D15 of Cycle 1, D1 for all the remaining cycles up to 28 days after the last IMP administration
5
Abnormalities in 12-lead ECG parameters (Phase 1)
Timeframe: Screening, D1 and D2 of Cycle 1, D1 for all the following cycles until withdrawal visit (within 5 days after the last IMP administration)
6
Changes in vital signs: SBP, DBP, respiratory rate and temperature (Phase 1)
Timeframe: Screening, D1 D8 D15 and D22 of Cycle 1, D1 for all the following cycles up to 28 days after the last IMP administration
7
Trial details
NCT IDNCT05312372
SponsorInstitut de Recherches Internationales Servier
✕. 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.
✕. 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.
Objective response per central review of antitumor activity (using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) (Phase 2)
Timeframe: Screening,and after the completion of every 2 cycles until disease progression