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
1 other identifier
interventional
120
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2026
Typical duration for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2026
CompletedFirst Posted
Study publicly available on registry
July 14, 2026
CompletedStudy Start
First participant enrolled
July 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
July 14, 2026
July 1, 2026
2.4 years
July 8, 2026
July 8, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Objective Response Rate (ORR)
Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by investigator based on RECIST version 1.1.
up to 24 months
Incidence and severity of adverse events (AEs) and serious adverse event(SAEs)
Incidence and severity of adverse events (AEs) and serious adverse event(SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v6.0, as well as clinically significant abnormal laboratory findings.
up to 24 months
Secondary Outcomes (7)
Progression-free survival (PFS)
up to 24 months
Duration of response (DOR)
up to 24 months
Disease control rate (DCR)
up to 24 months
Overall Survival (OS)
up to 24 months
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB500-ADC, SKB500-TAB and free payload
up to 24 months
- +2 more secondary outcomes
Other Outcomes (1)
Biomarkers
During the screening period, tumor tissue samples should be provided for PD-L1, B7-H3, SLFN11 testing
Study Arms (4)
Cohort 1. SKB500+Tislelizumab
EXPERIMENTALParticipants will receive Tislelizumab followed by SKB500
Cohort 2. SKB500+Tislelizumab+5-FU
EXPERIMENTALParticipants will receive Tislelizumab followed by SKB500, 5-FU
Cohort 3. SKB500+Tislelizumab+ Cisplatin
EXPERIMENTALParticipants will receive Tislelizumab followed by SKB500, Cisplatin
Cohort 4. SKB500+Tislelizumab+ Cisplatin+5-FU
EXPERIMENTALParticipants will receive Tislelizumab followed by SKB500, Cisplatin, 5-FU
Interventions
SKB500 will be administered as an intravenous infusion(IV), every 3 weeks on Day 1 of each 21-day cycle.
Tislelizumab will be administered as an intravenous infusion(IV) every 3 weeks on Day 1 of each 21-day cycle .
Cisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
5-FU will be administered as an intravenous infusion(IV) every 3 weeks on Day 1-5 of each 21-day cycle.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2026
First Posted
July 14, 2026
Study Start
July 30, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2029
Last Updated
July 14, 2026
Record last verified: 2026-07