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SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma

8. juli 2026 opdateret af: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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), randomized enrollment phase 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, antibodydrug conjugate (ADC), and other agents.
  13. Previously received treatment with an ADC that consists of a topoisomerase l inhibitor.
  14. Pregnant or lactating women.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1. SKB500+Tislelizumab
Participants will receive Tislelizumab followed by SKB500
Medicin: SKB500
SKB500 will be administered as an intravenous infusion(IV), every 3 weeks on Day 1 of each 21-day cycle.
Medicin: Tislelizumab
Tislelizumab will be administered as an intravenous infusion(IV) every 3 weeks on Day 1 of each 21-day cycle .
Eksperimentel: Cohort 2. SKB500+Tislelizumab+5-FU
Participants will receive Tislelizumab followed by SKB500, 5-FU
Medicin: SKB500
SKB500 will be administered as an intravenous infusion(IV), every 3 weeks on Day 1 of each 21-day cycle.
Medicin: Tislelizumab
Tislelizumab will be administered as an intravenous infusion(IV) every 3 weeks on Day 1 of each 21-day cycle .
Medicin: 5 - FU
5-FU will be administered as an intravenous infusion(IV) every 3 weeks on Day 1-5 of each 21-day cycle.
Eksperimentel: Cohort 3. SKB500+Tislelizumab+ Cisplatin
Participants will receive Tislelizumab followed by SKB500, Cisplatin
Medicin: SKB500
SKB500 will be administered as an intravenous infusion(IV), every 3 weeks on Day 1 of each 21-day cycle.
Medicin: Tislelizumab
Tislelizumab will be administered as an intravenous infusion(IV) every 3 weeks on Day 1 of each 21-day cycle .
Medicin: Cisplatin
Cisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Eksperimentel: Cohort 4. SKB500+Tislelizumab+ Cisplatin+5-FU
Participants will receive Tislelizumab followed by SKB500, Cisplatin, 5-FU
Medicin: SKB500
SKB500 will be administered as an intravenous infusion(IV), every 3 weeks on Day 1 of each 21-day cycle.
Medicin: Tislelizumab
Tislelizumab will be administered as an intravenous infusion(IV) every 3 weeks on Day 1 of each 21-day cycle .
Medicin: 5 - FU
5-FU will be administered as an intravenous infusion(IV) every 3 weeks on Day 1-5 of each 21-day cycle.
Medicin: Cisplatin
Cisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR)
Tidsramme: up to 24 months
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)
Tidsramme: up to 24 months
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progressionsfri overlevelse (PFS)
Tidsramme: op til 24 måneder
Progressionfri overlevelse (PFS) blev defineret som tiden fra baseline til den tidligste dato for den første objektive dokumentation af progressiv sygdom (PD) eller død af enhver årsag.
op til 24 måneder
Overall Survival (OS)
Tidsramme: op til 24 måneder
Tiden fra første dosis til død af enhver årsag.
op til 24 måneder
Duration of response (DOR)
Tidsramme: up to 24 months
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response[CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DOR was measured for responding participants (PR or CR) only.
up to 24 months
Disease control rate (DCR)
Tidsramme: up to 24 months
Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate.
up to 24 months
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB500-ADC, SKB500-TAB and free payload
Tidsramme: up to 24 months
Cycle 1, 2, 4, 6, 8: pre-dose, post-dose; 12,16, every 8 cycles starting from Cycle 16 Day 1: pre-dose(each cycle is 21 days).
up to 24 months
Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of SKB500-ADC, SKB500-TAB and free payload
Tidsramme: up to 24 months
Cycle 1, 2, 4, 6, 8: pre-dose, post-dose; 12,16, every 8 cycles starting from Cycle 16 Day 1: pre-dose(each cycle is 21 days) .
up to 24 months
Anti-drug Antibodies (ADA) for SKB500
Tidsramme: up to 24 months
Cycle 1, 2, 4, 8, every subsequent 8 cycles starting from Cycle 8 Day 1 : pre-dose (each cycle is 21 days).
up to 24 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biomarkers
Tidsramme: During the screening period, tumor tissue samples should be provided for PD-L1, B7-H3, SLFN11 testing
Correlation between the expression level of PD-L1, B7-H3, SLFN11 in tumor tissues and the efficacy.
During the screening period, tumor tissue samples should be provided for PD-L1, B7-H3, SLFN11 testing

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. juli 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SKB500-Ⅱ-04

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Esophageal pladecellekarcinom

Kliniske forsøg med SKB500

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Betingelser

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Placeringer

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