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Esophageal cancer drug combo trial pulled before it began

NCT ID NCT05312372

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial aimed to test a new drug called S095033 combined with the chemotherapy paclitaxel in people with advanced or metastatic esophageal squamous cell carcinoma. The goal was to check safety, tolerability, and signs of tumor shrinkage. However, the study was withdrawn before any participants were enrolled, so no results are available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
S095033 (MAT2A inhibitor) combined with paclitaxel
What this could lead to
If successful, this combination could offer a new treatment option for advanced esophageal cancer.
What could go wrong
The trial was withdrawn before enrolling any participants, so no data is available. It is unclear if the combination is safe or effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Expected to start

May 2025

An estimate. Start dates often move.

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 11. For participants with MTAP deletion, evidence of homozygous loss of MTAP in archival or fresh tumor tissue. 12. For participants with MTAP wild type, evidence of the presence of MTAP in archival or fresh tumor tissue. 13. Adequate hematological function based on the last assessment performed within 7 days prior to the first IMP administration. 14. 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. 15. Adequate renal function based on the last assessment performed within 7 days prior to the first IMP administration. 16. Adequate hepatic function based on the last assessment performed within 7 days prior to the first IMP administration. 17. Serum albumin ≥ 3 g/dL. 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. History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization. 12. 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. 13. 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. 14. Severe or uncontrolled active acute or chronic infection. 15. Participants with a known clinically significant cardiovascular disease or condition. 16. Participants with thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first IMP administration. 17. Symptoms suggesting central nervous system involvement, including symptomatic metastasis, for which treatment is required. 18. Participants who have received systemic anticancer treatment or radiotherapy less than 2 weeks before the first dose of S095033. 19. 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. 20. Any contraindication to the use of paclitaxel as per standard labelling and local guidance. 21. For prior and forbidden concomitant medication.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

More trials for these conditions

Other studies related to the condition(s) this trial covers.