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A Study of SKB571 in Participants With Gastrointestinal Tumors

2. august 2026 opdateret af: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 in Participants With Gastrointestinal Tumors

This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 in participants with gastrointestinal tumors.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a multicenter, open-label, Phase II clinical study to evaluate the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571 in participants with gastrointestinal tumors. Approximately 120 subjects will be enrolled in this study, including 4 cohorts with approximately 20-30 participants enrolled in each cohort.

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
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 404000
        • Rekruttering
        • Chongqing University Three Gorges Hospital
        • Ledende efterforsker:
          • Li Zhang
    • Fujian
      • Fuzhou, Fujian, Kina, 350014
        • Ikke rekrutterer endnu
        • Fujian Cancer Hospital
        • Ledende efterforsker:
          • Yigui Chen
      • Xiamen, Fujian, Kina, 361003
        • Rekruttering
        • The First Affiliated Hospital of Xiamen University
        • Ledende efterforsker:
          • Jiayi Li
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Rekruttering
        • Sun Yat-sen University Cancer Center
        • Ledende efterforsker:
          • Ruihua Xu
      • Guangzhou, Guangdong, Kina, 510655
        • Ikke rekrutterer endnu
        • The Sixth Affiliated Hospital, Sun Yat-sen University
        • Ledende efterforsker:
          • Yanhong Deng
    • Guangxi
      • Nanning, Guangxi, Kina, 530021
        • Rekruttering
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Ledende efterforsker:
          • Yuhua Cao
    • Hebei
      • Shijiazhuang, Hebei, Kina, 050011
        • Ikke rekrutterer endnu
        • The Fourth Hospital of Hebei Medical University
        • Ledende efterforsker:
          • Jian Shi
        • Ledende efterforsker:
          • Fengbin Zhang
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150081
        • Ikke rekrutterer endnu
        • Tumor Hospital of Harbin Medical University
        • Ledende efterforsker:
          • Yanqiao Zhang
    • Henan
      • Luoyang, Henan, Kina, 471003
        • Rekruttering
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Ledende efterforsker:
          • Jun Yao
      • Zhengzhou, Henan, Kina, 450052
        • Rekruttering
        • The First Affiliated Hospital of Zhengzhou University
        • Ledende efterforsker:
          • Ruihua Zhao
      • Zhengzhou, Henan, Kina, 450008
        • Ikke rekrutterer endnu
        • Henan Cancer Hospital
        • Ledende efterforsker:
          • Yan Zhao
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • Rekruttering
        • Hunan Cancer Hospital
        • Ledende efterforsker:
          • Zhenyang Liu
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210009
        • Rekruttering
        • Jiangsu Cancer Hospital
        • Ledende efterforsker:
          • Xia He
        • Ledende efterforsker:
          • Sheng Li
      • Nanjing, Jiangsu, Kina, 210029
        • Rekruttering
        • Jiangsu Province Hospital
        • Ledende efterforsker:
          • Yanhong Gu
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330006
        • Ikke rekrutterer endnu
        • The Second Affiliated Hospital of Nanchang University
        • Ledende efterforsker:
          • Anwen Liu
        • Ledende efterforsker:
          • Hua Wang
      • Nanchang, Jiangxi, Kina, 3300029
        • Ikke rekrutterer endnu
        • Jiangxi Cancer Hospital
        • Ledende efterforsker:
          • Huiqing Zhang
    • Jilin
      • Changchun, Jilin, Kina, 130021
        • Rekruttering
        • The First Hospital of Jilin University
        • Ledende efterforsker:
          • Wei Li
    • Liaoning
      • Shenyang, Liaoning, Kina, 110001
        • Ikke rekrutterer endnu
        • The First Hospital of China Medical University
        • Ledende efterforsker:
          • Jinglei Qu
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710004
        • Rekruttering
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Ledende efterforsker:
          • Hui Guo
        • Ledende efterforsker:
          • Xiaoran Guo
    • Shandong
      • Jinan, Shandong, Kina, 250021
        • Rekruttering
        • Shandong Provincial Hospital
        • Ledende efterforsker:
          • Lei Cong
      • Jinan, Shandong, Kina, 250117
        • Rekruttering
        • Cancer Hospital of Shandong First Medical University
        • Ledende efterforsker:
          • Changzheng Li
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200127
        • Ikke rekrutterer endnu
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Ledende efterforsker:
          • Xiuying Xiao
    • Shanxi
      • Taiyuan, Shanxi, Kina, 030013
        • Ikke rekrutterer endnu
        • Shanxi Provincial Cancer Hospital
        • Ledende efterforsker:
          • Hongxia Lu
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Ikke rekrutterer endnu
        • Sichuan Cancer Hospital
        • Ledende efterforsker:
          • Yongdong Jin
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300060
        • Rekruttering
        • Tianjin Medical University Cancer Institute & Hospital
        • Ledende efterforsker:
          • Ting Deng

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. Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
  2. Participants must have histologically or cytologically confirmed gastrointestinal tumors.
  3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  5. Life expectancy ≥ 12 weeks as assessed by the investigator.
  6. Adequate organ and bone marrow function.
  7. Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
  8. Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.

Exclusion Criteria:

  1. Participants with other malignant tumors within 3 years before the first dose of study treatment.
  2. History or current metastases to central nervous system.
  3. Current uncontrolled concomitant diseases
  4. Clinically severe lung damage due to complications of lung disorder
  5. Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
  6. A history of severe skin diseases
  7. Unresolved toxicity from prior anti-tumor therapy
  8. Serious infection within 4 weeks before the first dose of study treatment
  9. Known active pulmonary tuberculosis.
  10. Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
  11. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
  12. Pregnant or breastfeeding women.
  13. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJ)
Medicin: SKB571 for injection
Intravenous(IV) infusion(Q3W)
Eksperimentel: Oesophageal Squamous Cell Carcinoma (ESCC)
Medicin: SKB571 for injection
Intravenous(IV) infusion(Q3W)
Eksperimentel: Colorectal Adenocarcinoma (CRC)
Medicin: SKB571 for injection
Intravenous(IV) infusion(Q3W)
Eksperimentel: Hepatocellular Carcinoma (HCC) or Bile Duct Cancer (BTC) or other types of gastrointestinal tumors
Medicin: SKB571 for injection
Intravenous(IV) infusion(Q3W)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Objektiv svarprocent (ORR)
Tidsramme: Op til cirka 24 måneder
Op til cirka 24 måneder

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS)
Tidsramme: Up to approximately 24 months
Up to approximately 24 months
Safety and tolerability
Tidsramme: Up to approximately 24 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results, etc.
Up to approximately 24 months
Maximum Plasma Concentration (Cmax) of SKB571-ADC
Tidsramme: Up to approximately 24 months
Blood Samples will be collected to determine the Cmax of SKB571-ADC in the plasma
Up to approximately 24 months
Immunogenicity
Tidsramme: Up to approximately 24 months
Blood Samples will be collected to measure Anti-drug antibody (ADA) against SKB571 in the serum
Up to approximately 24 months
Minimum Plasma Concentration(Cmin) of SKB571-ADC
Tidsramme: Up to approximately 24 months
Blood samples will be collected to determine the Cmin of SKB571-ADC in the plasma
Up to approximately 24 months
Maximum Plasma Concentration(Cmax) of SKB571-TAb
Tidsramme: Up to approximately 24 months
Blood samples will be collected to determine the Cmax of SKB571-TAb in the plasma
Up to approximately 24 months
Minimum Plasma Concentration(Cmin) of SKB571-TAb
Tidsramme: Up to approximately 24 months
Blood Samples will be collected to determine the Cmin of SKB571-TAb in the plasma
Up to approximately 24 months
Maximum Plasma Concentration (Cmax) of unconjugated KL610348
Tidsramme: Up to approximately 24 months
Blood Samples will be collected to determine the Cmax of unconjugated KL610348 in the plasma
Up to approximately 24 months
Minimum Plasma Concentration(Cmin) of unconjugated KL610348
Tidsramme: Up to approximately 24 months
Blood Samples will be collected to determine the Cmin of unconjugated KL610348 in the plasma
Up to approximately 24 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between biomarkers and efficacy
Tidsramme: Up to approximately 24 months
To evaluate the correlation between the expression levels of tumor-related genes in tumor tissues and efficacy
Up to approximately 24 months

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 (Faktiske)

20. maj 2026

Primær færdiggørelse (Anslået)

31. august 2027

Studieafslutning (Anslået)

30. juni 2028

Datoer for studieregistrering

Først indsendt

14. april 2026

Først indsendt, der opfyldte QC-kriterier

26. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. august 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SKB571-II-04

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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