SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma

Starting soon · Phase 2

Conditions studied: Esophageal Squamous Cell Carcinoma

In brief

The purpose of this study is to evaluate the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with Esophageal Squamous Cell Carcinoma. The study is divided into three parts: the safety run-in phase, randomized enrollment phase and cohort expansion phase.

Key facts

Study ID

NCT07700667

Run by

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

People needed

120

Starts

2026-07-30

Expected to finish

2029-12-31

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years and ≤75 years
• 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.
• Participants are required to provide tumor tissue samples for biomarker analysis.
• Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 12 weeks.

You may not qualify if…

• Histology or cytology confirms the presence of concurrent adenocarcinoma components.
• Leptomeningeal, brainstem, spinal, spinal cord compression, or active CNS metastases.
• Risk of esophagotracheal/esophagopleural fistula, or symptomatic invasion/compression of vital organs/major blood vessels.
• Active autoimmune disease requiring systemic therapy within past 2 years.
• Weight loss ≥10% within 4 weeks prior to the first dose, or Nutritional Risk Index (NRI) < 83.5.
• Severe infection within 4 weeks or active infection requiring systemic treatment within 2 weeks pre-dose.
• Uncontrolled comorbidities (e.g., decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, Grade ≥2 peripheral neuropathy).
• 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).
• Uncontrolled hypertension, diabetes, or recurrent pleural/pericardial/abdominal effusion requiring drainage.
• History of interstitial lung disease (ILD) or noninfectious pneumonitis that require steroid treatment, or currently has ILD/noninfectious pneumonitis.
• Unresolved to grade ≤ 1 of prior anti-cancer treatment toxicities criteria per CTCAE v6.0.
• Previously received B7-H3-targeted agents, including antibody, antibodydrug conjugate (ADC), and other agents.
• Previously received treatment with an ADC that consists of a topoisomerase l inhibitor.
• Pregnant or lactating women.

Where it is running

• Jilin Cancer Hospital — Changchun, China
• Chengdu Fifth People's Hospital — Chengdu, China
• Sichuan Cancer Hospital & Institute — Chengdu, China
• West China Hospital, Sichuan University — Chengdu, China
• Chongqing University Three Gorges Hospital — Chongqing, China
• Fujian Cancer Hospital — Fuzhou, China
• Harbin Medical University Cancer Hospital — Ha’erbin, China
• Cancer Hospital of Shandong First Medical University — Jinan, China
• Yunnan Cancer Hospital — Kunming, China
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, China
• The Second Affiliated Hospital of Nanchang University — Nanchang, China
• Jiangsu Cancer Hospital — Nanjing, China
• Jiangsu Province Hospital — Nanjing, China
• Guangxi Medical University Cancer Hospital — Nanning, China
• Cancer Hospital of Dalian University of Technology — Shenyang, China
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, China
• Shiyan Renmin Hospital — Shiyan, China
• Shanxi Cancer Hospital — Taiyuan, China
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, China
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China
• Yichang Central People's Hospital — Yichang, China
• Henan Cancer Hospital — Zhengzhou, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China

Full record on ClinicalTrials.gov

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