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- Klinische proef NCT07814066
A Multicenter, Open-label, Phase II Umbrella Study to Evaluate the Efficacy and Safety of the Investigational Product in Participants With Advanced or Metastatic Pancreatic Cancer
7 september 2026 bijgewerkt door: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
This is a multicenter, open-label, Phase II umbrella study conducted in participants with advanced or metastatic pancreatic cancer.
This study has set up different cohorts to evaluate the efficacy and safety of multiple investigational products in pancreatic cancer.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
30
Fase
- Fase 2
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form.
- Histologically or cytologically confirmed advanced or metastatic pancreatic cancer.
- Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before the first dose.
- Participants who have adequate bone marrow, liver, kidney, and coagulation function.
- Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.
- Participants must voluntarily join this study, sign the informed consent form (ICF), and be able to comply with the visits and related procedures specified in the protocol.
Exclusion Criteria:
- History or current metastases to central nervous system.
- Histologically or cytologically confirmed other pathological types or differentiation combined with other pathological types.
- Subjects with other malignant tumors within 3 years prior to the first dose.
- Presence of any cardiovascular and cerebrovascular disorders or risk factors.
- Presence of uncontrolled systemic disease.
- Presence of clinically symptomatic or uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- History of interstitial lung disease (ILD) or non-infectious pneumonitis.
- Presence within 3 months before the first dose of other moderate to severe lung disorders.
- Tumor invasion or compression of surrounding vital organs and major blood vessels.
- Active severe digestive system diseases.
- Unresolved toxicity from prior anti-tumor therapy.
- Serious infection within 4 weeks before the first dose.
- Presence of active HIV, hepatitis B or hepatitis C or co-infection with HBV and HCV.
- Known history of allogeneic organ transplant or hematopoietic stem cell transplant.
- History of allergy to any component of the study drug or severe hypersensitivity to other monoclonal antibodies.
- 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.
- Participants who have received other investigational drug treatments within 4 weeks before the first dose.
- Pregnant or breastfeeding women.
- Known history of psychosis or drug abuse that prevents the participant from cooperating with the study.
- Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to higher medical risk and/or uncertainty in survival assessment, or may affect protocol compliance.
- Any condition that, in the investigator's opinion, interferes with the evaluation of the investigational product, participant safety, or interpretation of study results, or any other condition that the investigator deems unsuitable for participation in this study.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Cohort A: SKB571 monotherapy
|
q3w
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Objective response rate (ORR)
Tijdsspanne: Up to approximately 24 months.
|
ORR as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
|
Up to approximately 24 months.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Progression-free survival (PFS)
Tijdsspanne: Up to approximately 24 months.
|
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
|
Up to approximately 24 months.
|
|
Duration of Response (DOR)
Tijdsspanne: Up to approximately 24 months.
|
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
|
Up to approximately 24 months.
|
|
Disease control rate (DCR)
Tijdsspanne: Up to approximately 24 months.
|
Assessed by the investigators as per RECIST v1.1
|
Up to approximately 24 months.
|
|
Overall Survival (OS)
Tijdsspanne: Up to approximately 24 months.
|
Time from start of treatment to death due to any reason.
|
Up to approximately 24 months.
|
|
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Tijdsspanne: Up to approximately 24 months.
|
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results.
|
Up to approximately 24 months.
|
|
Maximum Plasma Concentration (Cmax) of the investigational product
Tijdsspanne: Up to approximately 24 months.
|
Blood Samples will be collected to determine the Cmax of the investigational product in the plasma.
|
Up to approximately 24 months.
|
|
Minimum Plasma Concentration (Cmin) of the investigational product
Tijdsspanne: Up to approximately 24 months.
|
Blood Samples will be collected to determine the Cmin of the investigational product in the plasma.
|
Up to approximately 24 months.
|
|
Immunogenicity of the investigational product
Tijdsspanne: Up to approximately 24 months.
|
Incidence of anti-drug antibody (ADA) against the investigational product.
|
Up to approximately 24 months.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
31 oktober 2026
Primaire voltooiing (Geschat)
28 februari 2028
Studie voltooiing (Geschat)
31 mei 2028
Studieregistratiedata
Eerst ingediend
2 september 2026
Eerst ingediend dat voldeed aan de QC-criteria
7 september 2026
Eerst geplaatst (Werkelijk)
10 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 september 2026
Laatste update ingediend die voldeed aan QC-criteria
7 september 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SKB-PDAC-01
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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