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New drug cocktail aims to shrink Hard-to-Treat esophageal tumors

NCT ID NCT07700667

Disease control Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This phase II trial tests a new drug called SKB500 in combination with standard chemotherapy and immunotherapy for people with advanced esophageal squamous cell carcinoma that cannot be removed by surgery. The study will evaluate how well the combination shrinks tumors and how safe it is. Participants receive the drugs by infusion every three weeks.

What this could mean

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

Active substance
a combination of SKB500, tislelizumab, cisplatin, and 5-FU
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced esophageal cancer that is hard to treat.
What could go wrong
This is an early phase II trial with a moderate number of participants, so results may not confirm effectiveness. Side effects from the drug combination could be significant.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 75 years

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. Age ≥18 years and ≤75 years 2. Histologically or cytologically confirmed unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), who are ineligible for curative-intent therapies: * Safety run-in phase (Cohort 1, 2 and 3): received no more than 1 prior line of systemic therapy for locally advanced or metastatic ESCC. * Safety run-in phase (Cohort 4), randomized enrollment phase and cohort expansion phase: no prior systemic therapy for locally advanced or metastatic ESCC. 3. Participants are required to provide tumor tissue samples for biomarker analysis. 4. Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Life expectancy ≥ 12 weeks. Exclusion Criteria: 1. Histology or cytology confirms the presence of concurrent adenocarcinoma components. 2. Leptomeningeal, brainstem, spinal, spinal cord compression, or active CNS metastases. 3. Risk of esophagotracheal/esophagopleural fistula, or symptomatic invasion/compression of vital organs/major blood vessels. 4. Active autoimmune disease requiring systemic therapy within past 2 years. 5. Weight loss ≥10% within 4 weeks prior to the first dose, or Nutritional Risk Index (NRI) \< 83.5. 6. Severe infection within 4 weeks or active infection requiring systemic treatment within 2 weeks pre-dose. 7. Uncontrolled comorbidities (e.g., decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, Grade ≥2 peripheral neuropathy). 8. Cardiovascular/cerebrovascular events within 6 months pre-dose (e.g., Myocardial Infarction, unstable angina, acute/persistent ischemia, Grade 3/4 Heart Failure, symptomatic/uncontrolled arrhythmia, Cerebrovascular Accident, Transient Ischemic Attack). 9. Uncontrolled hypertension, diabetes, or recurrent pleural/pericardial/abdominal effusion requiring drainage. 10. History of interstitial lung disease (ILD) or noninfectious pneumonitis that require steroid treatment, or currently has ILD/noninfectious pneumonitis. 11. Unresolved to grade ≤ 1 of prior anti-cancer treatment toxicities criteria per CTCAE v6.0. 12. Previously received B7-H3-targeted agents, including antibody, antibodydrug conjugate (ADC), and other agents. 13. Previously received treatment with an ADC that consists of a topoisomerase l inhibitor. 14. Pregnant or lactating women.

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Conditions

The condition(s) this trial relates to.

esophageal squamous cell carcinoma

As listed by the trial registrant

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

Esophageal squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Hospital of Dalian University of Technology

    RECRUITING

    Shenyang, China

  • Cancer Hospital of Shandong First Medical University

    RECRUITING

    Jinan, China

  • Cancer Hospital of Shantou University Medical College

    RECRUITING

    Shantou, China

  • Chengdu Fifth People's Hospital

    RECRUITING

    Chengdu, China

  • Chongqing University Three Gorges Hospital

    RECRUITING

    Chongqing, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Ha’erbin, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, China

  • Jiangsu Cancer Hospital

    RECRUITING

    Nanjing, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, China

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, China

  • Shanxi Cancer Hospital

    RECRUITING

    Taiyuan, China

  • Shiyan Renmin Hospital

    RECRUITING

    Shiyan, China

  • Sichuan Cancer Hospital & Institute

    RECRUITING

    Chengdu, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    RECRUITING

    Luoyang, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, China

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, China

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, China

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, China

  • Yichang Central People's Hospital

    RECRUITING

    Yichang, China

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, China

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