SKB500 combinations for esophageal squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II, multicenter, open-label study evaluating the safety, tolerability and preliminary antitumor activity of SKB500 in combination with other agents in patients with ESCC. The trial has two parts: a safety run-in to establish tolerability and a cohort expansion to further assess outcomes. Eligible participants are adults up to 75 with unresectable, recurrent, or metastatic ESCC, measurable disease, and adequate performance status, including some cohorts with no prior systemic therapy. Biomarker analysis requires tumor tissue samples. Exclusion criteria include presence of adenocarcinoma components and certain central nervous system or spinal conditions. Treatment arms may include SKB500 with tislelizumab, cisplatin, and 5-FU, delivered at multiple sites in China.

Why it matters

Who can join: the full rules

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) 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, antibody-drug conjugate (ADC), and other agents.
13. Previously received any agent containing a topoisomerase I inhibitor (including chemotherapy and antibody-drug conjugate(ADC)).
14. Pregnant or lactating women.

Where it's running

• Jilin Cancer Hospital
  Changchun, China Recruiting
• Chengdu Fifth People's Hospital
  Chengdu, China Recruiting
• Sichuan Cancer Hospital & Institute
  Chengdu, China Recruiting
• West China Hospital, Sichuan University
  Chengdu, China Recruiting
• Chongqing University Three Gorges Hospital
  Chongqing, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, China Recruiting

Study contacts

• Study coordinator: Qing Yan
• Email: qingyan@kelun.com
• Phone: 028-67255480

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer

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• Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC

  This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.

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• Neoadjuvant Cardonilizumab With Chemotherapy Before Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma

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• Surgery or chemoradiotherapy after neoadjuvant immunochemotherapy for esophageal squamous cell carcinoma

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• Tislelizumab plus chemotherapy for advanced gastric, gastroesophageal, and esophageal squamous cancers in U.S. racial and ethnic minority patients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.