Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren