Not yet recruiting NCT07700667
SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SKB500, Tislelizumab, Cisplatin, 5 - FU.
- Who it may be relevant to
- Registry conditions: Esophageal Squamous Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma
Overview
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.
Detailed description
This is a Phase II, multicenter, open-label study 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.
Interventions
- Drug SKB500
SKB500 will be administered as an intravenous infusion(IV), every 3 weeks on Day 1 of each 21-day cycle. - Drug Tislelizumab
Tislelizumab will be administered as an intravenous infusion(IV) every 3 weeks on Day 1 of each 21-day cycle . - Drug Cisplatin
Cisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle. - Drug 5 - FU
5-FU will be administered as an intravenous infusion(IV) every 3 weeks on Day 1-5 of each 21-day cycle.
Primary outcome measures
- Objective Response Rate (ORR) [Time frame: up to 24 months]
- Incidence and severity of adverse events (AEs) and serious adverse event(SAEs) [Time frame: up to 24 months]
Secondary outcome measures (7)
- Progression-free survival (PFS) [Time frame: up to 24 months]
- Duration of response (DOR) [Time frame: up to 24 months]
- Disease control rate (DCR) [Time frame: up to 24 months]
- Overall Survival (OS) [Time frame: up to 24 months]
- Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB500-ADC, SKB500-TAB and free payload [Time frame: up to 24 months]
- Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of SKB500-ADC, SKB500-TAB and free payload [Time frame: up to 24 months]
- Anti-drug Antibodies (ADA) for SKB500 [Time frame: up to 24 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 23 centers
- Jilin Cancer Hospital — Changchun
- Chengdu Fifth People's Hospital — Chengdu
- Sichuan Cancer Hospital & Institute — Chengdu
- West China Hospital, Sichuan University — Chengdu
- Chongqing University Three Gorges Hospital — Chongqing
- Fujian Cancer Hospital — Fuzhou
- Harbin Medical University Cancer Hospital — Ha’erbin
- Cancer Hospital of Shandong First Medical University — Jinan
- … and 15 more centers
Identifiers
NCT: NCT07700667 · SKB500-Ⅱ-04