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A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)

26. maj 2026 opdateret af: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)

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 Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC).

Studieoversigt

Status

Ikke rekrutterer endnu

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 SKB571Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC). Approximately 150 subjects will be enrolled in this study, including 3 cohorts.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

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
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100142
        • Peking University Cancer Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400037
        • Xinqiao Hospital of Army Medical University
        • Ledende efterforsker:
          • Zhi Xu
    • Fujian
      • Fuzhou, Fujian, Kina, 350014
        • Fujian Provincial Cancer Hospital
        • Ledende efterforsker:
          • Jing Zhang
      • Xiamen, Fujian, Kina, 361003
        • The First Affiliated Hospital of Xiamen University
        • Ledende efterforsker:
          • Jingxun Wu
    • Guangdong
      • Dongguan, Guangdong, Kina, 523018
        • Dongguan People's Hospital
        • Ledende efterforsker:
          • Guanming Jiang
      • Guangzhou, Guangdong, Kina, 510060
        • Sun yat-sen University Cancer Center
        • Ledende efterforsker:
          • Li Zhang
      • Guangzhou, Guangdong, Kina, 510120
        • Guangzhou Medical University First Affiliated Hospital
        • Ledende efterforsker:
          • Chengzhi Zhou
    • Guangxi
      • Guilin, Guangxi, Kina, 541001
        • Guilin Medical University First Affiliated Hospital
        • Ledende efterforsker:
          • Yanyi Zhao
      • Nanning, Guangxi, Kina, 530021
        • Guangxi Medical University Affiliated Tumor Hospital
        • Ledende efterforsker:
          • Qitao Yu
        • Ledende efterforsker:
          • Yun Zhao
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150081
        • Harbin Medical University Cancer Hospital
        • Ledende efterforsker:
          • Yan Yu
        • Ledende efterforsker:
          • Qingwei Meng
    • Henan
      • Zhengzhou, Henan, Kina, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, Kina, 450008
        • Henan Cancer Hospital
        • Ledende efterforsker:
          • Qiming Wang
    • Hubei
      • Xiangyang, Hubei, Kina, 441021
        • Xiangyang Central Hospital
        • Ledende efterforsker:
          • Tienan Yi
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • Hunan Cancer Hospital
        • Ledende efterforsker:
          • Bolin Chen
        • Ledende efterforsker:
          • Xingxiang Pu
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210029
        • Jiangsu Province Hospital
        • Ledende efterforsker:
          • Wangjian Zha
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330029
        • Jiangxi Cancer Hospital
        • Ledende efterforsker:
          • Zhentian Liu
    • Jilin
      • Changchun, Jilin, Kina, 130012
        • Jilin Cancer Hospital
        • Ledende efterforsker:
          • Haifeng Liu
    • Liaoning
      • Shenyang, Liaoning, Kina, 110004
        • Shengjing Hospital Of China Medical University
        • Ledende efterforsker:
          • Wei Zheng
    • Shandong
      • Jinan, Shandong, Kina, 250117
        • Shandong Cancer Hospital
        • Ledende efterforsker:
          • Yan Zhang
        • Ledende efterforsker:
          • Haiyong Wang
    • Shanxi
      • Taiyuan, Shanxi, Kina, 030013
        • Shanxi Cancer Hospital
        • Ledende efterforsker:
          • Wei Guo
      • Xi’an, Shanxi, Kina, 710061
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Ledende efterforsker:
          • Yu Yao
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • West China Hospital, Sichuan University
        • Ledende efterforsker:
          • Guowei Che
      • Chengdu, Sichuan, Kina, 610041
        • Sichuan Cancer Hospital & Institute
        • Ledende efterforsker:
          • Wenxiu Yao
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300060
        • Tianjin Cancer Hospital
        • Ledende efterforsker:
          • Liuchun Wang
    • Xinjiang Uygur Autonomous Region
      • Ürümqi, Xinjiang Uygur Autonomous Region, Kina, 830011
        • Xinjiang Medical University Affiliated Tumor Hospital
    • Yunnan
      • Kunming, Yunnan, Kina, 650118
        • Yunnan Cancer Hospital
        • Ledende efterforsker:
          • Runxiang Yang
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310022
        • Zhejiang Cancer Hospital
        • Ledende efterforsker:
          • Xinmin Yu

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 non-small cell lung cancer (NSCLC).
  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. Active or untreated central nervous system (CNS) metastasis.
  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: NSCLC with sensitive EGFR mutations
Medicin: SKB571 for injection
Intravenous(IV) infusion(Q3W)
Medicin: Osimertinib
orally once daily
Medicin: Furmonertinib
orally once daily
Eksperimentel: NSCLC with EGFR wild-type
Medicin: SKB571 for injection
Intravenous(IV) infusion(Q3W)
Medicin: carboplatin
Intravenous(IV) infusion(Q3W)
Medicin: Cisplatin
Intravenous(IV) infusion(Q3W)
Medicin: Pembrolizumab
Intravenous(IV) infusion(Q3W)
Eksperimentel: NSCLC with uncommon EGFR mutations
Medicin: SKB571 for injection
Intravenous(IV) infusion(Q3W)
Medicin: Furmonertinib
orally once daily
Medicin: carboplatin
Intravenous(IV) infusion(Q3W)
Medicin: Cisplatin
Intravenous(IV) infusion(Q3W)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Objektiv svarprocent (ORR)
Tidsramme: Op til cirka 36 måneder
Op til cirka 36 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 36 months
Up to approximately 36 months
Safety and tolerability
Tidsramme: Up to approximately 36 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 36 months
Maximum Plasma Concentration (Cmax) of SKB571-ADC
Tidsramme: Up to approximately 36 months
Blood Samples will be collected to determine the Cmax of SKB571-ADC in the plasma
Up to approximately 36 months
Immunogenicity
Tidsramme: Up to approximately 36 months
Blood Samples will be collected to measure Anti-drug antibody (ADA) against SKB571 in the serum
Up to approximately 36 months
Minimum Plasma Concentration(Cmin) of SKB571-ADC
Tidsramme: Up to approximately 36 months
Blood samples will be collected to determine the Cmin of SKB571-ADC in the plasma
Up to approximately 36 months
Maximum Plasma Concentration(Cmax) of SKB571-TAb
Tidsramme: Up to approximately 36 months
Blood samples will be collected to determine the Cmax of SKB571-TAb in the plasma
Up to approximately 36 months
Minimum Plasma Concentration(Cmin) of SKB571-TAb
Tidsramme: Up to approximately 36 months
Blood Samples will be collected to determine the Cmin of SKB571-TAb in the plasma
Up to approximately 36 months
Maximum Plasma Concentration (Cmax) of unconjugated KL610348
Tidsramme: Up to approximately 36 months
Blood Samples will be collected to determine the Cmax of unconjugated KL610348 in the plasma
Up to approximately 36 months
Minimum Plasma Concentration(Cmin) of unconjugated KL610348
Tidsramme: Up to approximately 36 months
Blood Samples will be collected to determine the Cmin of unconjugated KL610348 in the plasma
Up to approximately 36 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between biomarkers and efficacy
Tidsramme: Up to approximately 36 months
To evaluate the correlation between the expression levels of tumor-related genes in tumor tissues and efficacy
Up to approximately 36 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.

Efterforskere

  • Studieleder: Xin Li, MD, 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)

31. juli 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

26. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SKB571-II-05

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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