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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 2
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: Cohort A: SKB571 monotherapy
|
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|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Objective response rate (ORR)
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression-free survival (PFS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Up to approximately 24 months.
|
Assessed by the investigators as per RECIST v1.1
|
Up to approximately 24 months.
|
|
Overall Survival (OS)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to approximately 24 months.
|
Incidence of anti-drug antibody (ADA) against the investigational product.
|
Up to approximately 24 months.
|
Collaboratori e investigatori
Sponsor
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- SKB-PDAC-01
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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