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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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 2

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:

  • 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.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort A: SKB571 monotherapy
q3w

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective response rate (ORR)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival (PFS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Up to approximately 24 months.
Assessed by the investigators as per RECIST v1.1
Up to approximately 24 months.
Overall Survival (OS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to approximately 24 months.
Incidence of anti-drug antibody (ADA) against the investigational product.
Up to approximately 24 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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. oktober 2026

Primær færdiggørelse (Anslået)

28. februar 2028

Studieafslutning (Anslået)

31. maj 2028

Datoer for studieregistrering

Først indsendt

2. september 2026

Først indsendt, der opfyldte QC-kriterier

7. september 2026

Først opslået (Faktiske)

10. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. september 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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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