RecruitingPhase 2NCT07700667

SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma

A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma


Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Enrollment

120 participants

Start Date

Aug 13, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 5 - FU, a drug called Cisplatin, and others for people with esophageal squamous cell carcinoma. The study is currently recruiting participants at 24 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSKB500

SKB500 will be administered as an intravenous infusion(IV), every 3 weeks on Day 1 of each 21-day cycle.

DRUGTislelizumab

Tislelizumab will be administered as an intravenous infusion(IV) every 3 weeks on Day 1 of each 21-day cycle .

DRUGCisplatin

Cisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

DRUG5 - FU

5-FU will be administered as an intravenous infusion(IV) every 3 weeks on Day 1-5 of each 21-day cycle.


Locations(24)

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 Shantou University Medical College

Shantou, 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

View Full Details on ClinicalTrials.gov

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NCT07700667


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