A Study of SKB571 in Participants With Gastrointestinal Tumors
2. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
120
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Xin Li, MD
- Telefonnummer: 86-13311373861
- E-post: lixin@kelun.com
Studiesteder
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Kina, 404000
- Rekruttering
- Chongqing University Three Gorges Hospital
-
Hovedetterforsker:
- Li Zhang
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350014
- Har ikke rekruttert ennå
- Fujian Cancer Hospital
-
Hovedetterforsker:
- Yigui Chen
-
Xiamen, Fujian, Kina, 361003
- Rekruttering
- The First Affiliated Hospital of Xiamen University
-
Hovedetterforsker:
- Jiayi Li
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510060
- Rekruttering
- Sun Yat-sen University Cancer Center
-
Hovedetterforsker:
- Ruihua Xu
-
Guangzhou, Guangdong, Kina, 510655
- Har ikke rekruttert ennå
- The Sixth Affiliated Hospital, Sun Yat-sen University
-
Hovedetterforsker:
- Yanhong Deng
-
-
Guangxi
-
Nanning, Guangxi, Kina, 530021
- Rekruttering
- The People's Hospital of Guangxi Zhuang Autonomous Region
-
Hovedetterforsker:
- Yuhua Cao
-
-
Hebei
-
Shijiazhuang, Hebei, Kina, 050011
- Har ikke rekruttert ennå
- The Fourth Hospital of Hebei Medical University
-
Hovedetterforsker:
- Jian Shi
-
Hovedetterforsker:
- Fengbin Zhang
-
-
Heilongjiang
-
Harbin, Heilongjiang, Kina, 150081
- Har ikke rekruttert ennå
- Tumor Hospital of Harbin Medical University
-
Hovedetterforsker:
- Yanqiao Zhang
-
-
Henan
-
Luoyang, Henan, Kina, 471003
- Rekruttering
- The First Affiliated Hospital of Henan University of Science and Technology
-
Hovedetterforsker:
- Jun Yao
-
Zhengzhou, Henan, Kina, 450052
- Rekruttering
- The First Affiliated Hospital of Zhengzhou University
-
Hovedetterforsker:
- Ruihua Zhao
-
Zhengzhou, Henan, Kina, 450008
- Har ikke rekruttert ennå
- Henan Cancer Hospital
-
Hovedetterforsker:
- Yan Zhao
-
-
Hunan
-
Changsha, Hunan, Kina, 410013
- Rekruttering
- Hunan Cancer Hospital
-
Hovedetterforsker:
- Zhenyang Liu
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210009
- Rekruttering
- Jiangsu Cancer Hospital
-
Hovedetterforsker:
- Xia He
-
Hovedetterforsker:
- Sheng Li
-
Nanjing, Jiangsu, Kina, 210029
- Rekruttering
- Jiangsu Province Hospital
-
Hovedetterforsker:
- Yanhong Gu
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330006
- Har ikke rekruttert ennå
- The Second Affiliated Hospital of Nanchang University
-
Hovedetterforsker:
- Anwen Liu
-
Hovedetterforsker:
- Hua Wang
-
Nanchang, Jiangxi, Kina, 3300029
- Har ikke rekruttert ennå
- Jiangxi Cancer Hospital
-
Hovedetterforsker:
- Huiqing Zhang
-
-
Jilin
-
Changchun, Jilin, Kina, 130021
- Rekruttering
- The First Hospital of Jilin University
-
Hovedetterforsker:
- Wei Li
-
-
Liaoning
-
Shenyang, Liaoning, Kina, 110001
- Har ikke rekruttert ennå
- The First Hospital of China Medical University
-
Hovedetterforsker:
- Jinglei Qu
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina, 710004
- Rekruttering
- The Second Affiliated Hospital of Xi'an Jiaotong University
-
Hovedetterforsker:
- Hui Guo
-
Hovedetterforsker:
- Xiaoran Guo
-
-
Shandong
-
Jinan, Shandong, Kina, 250021
- Rekruttering
- Shandong Provincial Hospital
-
Hovedetterforsker:
- Lei Cong
-
Jinan, Shandong, Kina, 250117
- Rekruttering
- Cancer Hospital of Shandong First Medical University
-
Hovedetterforsker:
- Changzheng Li
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200127
- Har ikke rekruttert ennå
- Renji Hospital, Shanghai Jiao Tong University School of Medicine
-
Hovedetterforsker:
- Xiuying Xiao
-
-
Shanxi
-
Taiyuan, Shanxi, Kina, 030013
- Har ikke rekruttert ennå
- Shanxi Provincial Cancer Hospital
-
Hovedetterforsker:
- Hongxia Lu
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610041
- Har ikke rekruttert ennå
- Sichuan Cancer Hospital
-
Hovedetterforsker:
- Yongdong Jin
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300060
- Rekruttering
- Tianjin Medical University Cancer Institute & Hospital
-
Hovedetterforsker:
- Ting Deng
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
- Participants must have histologically or cytologically confirmed gastrointestinal tumors.
- At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks as assessed by the investigator.
- Adequate organ and bone marrow function.
- Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
- 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:
- Participants with other malignant tumors within 3 years before the first dose of study treatment.
- History or current metastases to central nervous system.
- Current uncontrolled concomitant diseases
- Clinically severe lung damage due to complications of lung disorder
- Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
- A history of severe skin diseases
- Unresolved toxicity from prior anti-tumor therapy
- Serious infection within 4 weeks before the first dose of study treatment
- Known active pulmonary tuberculosis.
- 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.
- Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
- Pregnant or breastfeeding women.
- Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJ)
|
Intravenous(IV) infusion(Q3W)
|
|
Eksperimentell: Oesophageal Squamous Cell Carcinoma (ESCC)
|
Intravenous(IV) infusion(Q3W)
|
|
Eksperimentell: Colorectal Adenocarcinoma (CRC)
|
Intravenous(IV) infusion(Q3W)
|
|
Eksperimentell: Hepatocellular Carcinoma (HCC) or Bile Duct Cancer (BTC) or other types of gastrointestinal tumors
|
Intravenous(IV) infusion(Q3W)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Objektiv responsrate (ORR)
Tidsramme: Opptil ca 24 måneder
|
Opptil ca 24 måneder
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. mai 2026
Primær fullføring (Antatt)
31. august 2027
Studiet fullført (Antatt)
30. juni 2028
Datoer for studieregistrering
Først innsendt
14. april 2026
Først innsendt som oppfylte QC-kriteriene
26. april 2026
Først lagt ut (Faktiske)
4. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. august 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SKB571-II-04
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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Nei
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