- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
30
Fas
- Fas 2
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Cohort A: SKB571 monotherapy
|
q3w
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Objective response rate (ORR)
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-free survival (PFS)
Tidsram: 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)
Tidsram: 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)
Tidsram: Up to approximately 24 months.
|
Assessed by the investigators as per RECIST v1.1
|
Up to approximately 24 months.
|
|
Overall Survival (OS)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to approximately 24 months.
|
Incidence of anti-drug antibody (ADA) against the investigational product.
|
Up to approximately 24 months.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
31 oktober 2026
Primärt slutförande (Beräknad)
28 februari 2028
Avslutad studie (Beräknad)
31 maj 2028
Studieregistreringsdatum
Först inskickad
2 september 2026
Först inskickad som uppfyllde QC-kriterierna
7 september 2026
Första postat (Faktisk)
10 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 september 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SKB-PDAC-01
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .