- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07803783
A Study to Compare the Efficacy and Safety of YL201 With Standard Chemotherapy in Patients With Metastatic Pancreatic Cancer After Failure of Gemcitabine-Based Systemic Chemotherapy
A Randomized, Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of YL201 Versus Liposomal Irinotecan in Combination With 5-Fluorouracil/Leucovorin in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed Prior Gemcitabine-based Systemic Therapy
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: MediLink Study Team
- Numéro de téléphone: +86 512 62858368
- E-mail: clinicaltrials@medilinkthera.com
Lieux d'étude
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Chine, 200127
- Shanghai Jiaotong University School of Medicine
-
Contact:
- Study Coordinator
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Participants must voluntarily sign a written informed consent form (ICF) and be willing and able to comply with protocol requirements.
- Participants must be ≥18 and ≤75 years of age.
- Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Participants must have a life expectancy of at least 3 months.
- Participants must have histologically or cytologically confirmed incurable metastatic pancreatic ductal adenocarcinoma (PDAC).
- Participants must have received and failed only one prior line of gemcitabine-based systemic therapy.
- Participants must have at least one measurable lesion according to RECIST v1.1.
- Participants must have adequate organ function as defined in the protocol.
- Participants must agree to follow the contraception requirements specified in the protocol.
Exclusion Criteria:
- Participants with another malignancy within 5 years before randomization.
- Participants with pathologically confirmed pancreatic cancer other than PDAC.
- Participants who have previously received B7-H3-targeted therapy.
- Participants who have previously received topoisomerase I inhibitor or antibody-drug conjugate containing topoisomerase I inhibitor.
- Participants who are concurrently enrolled in another clinical study, unless it is an observational, non-interventional study or the participant is in the follow-up period of an interventional study.
- Participants who have not met the protocol-specified washout requirements for prior systemic therapy, relevant concomitant medications, radiotherapy, or surgery before randomization, or who have not adequately recovered from prior surgery or are planning to undergo major surgery during the study.
- Participants with protocol-specified exclusionary conditions related to central nervous system (CNS) metastases, history of transplantation, immunosuppressive therapy, live vaccine administration, or autoimmune or inflammatory diseases.
- Participants with uncontrolled or clinically significant concomitant diseases, including serious gastrointestinal, cardiovascular or cerebrovascular, pulmonary, thromboembolic, bleeding-related, effusion-related, or ascites-related safety risks.
- Participants with recent serious infection, active infection, active tuberculosis or syphilis, HIV positivity or immunodeficiency, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Participants with unresolved toxicity from prior anticancer therapy that has not recovered to the level specified in the protocol.
- Participants with known hypersensitivity to any component of the study treatment, or a history of severe hypersensitivity reactions or severe infusion-related reactions.
- Participants who are pregnant or breastfeeding, planning to become pregnant or breastfeed, or who have any other medical, psychiatric, social, or compliance-related factors that, in the investigator's opinion, would make them unsuitable for participation in the study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Tambotatug pelitecan
Tambotatug pelitecan, monotherapy
|
Drug: Tambotatug pelitecan 2.0mg/kg (maximum 200mg) Intravenous infusion Every 3 weeks Treatment will continue until disease progression or unacceptable toxicity.
Autres noms:
|
|
Comparateur actif: Chemotherapy
Active comparator: nal-IRI+5-FU/LV
|
Liposomal irinotecan Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. 5 Fluorouracil Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. Leucovorin Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
PFS by BICR
Délai: Up to approximately 2 years
|
Progression-free Survival (PFS) is assessed by Blinded Independent Central Review(BICR) per response evaluation criteria in solid tumors (RECIST) v1.1
|
Up to approximately 2 years
|
|
OS
Délai: Up to approximately 2 years
|
OS is defined as the time from randomization until death from any cause.
|
Up to approximately 2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
PFS by investigator
Délai: Up to approximately 2 year
|
PFS per RECIST v1.1, as assessed by Investigator
|
Up to approximately 2 year
|
|
ORR
Délai: Up to approximately 2 years
|
Objective Response Rate (ORR), as assessed by BICR and Investigator
|
Up to approximately 2 years
|
|
DCR
Délai: Up to approximately 2 years
|
Disease Control Rate (DCR), as assessed by BICR and Investigator
|
Up to approximately 2 years
|
|
DoR
Délai: Up to approximately 2 years
|
Duration of Response (DoR), as assessed by BICR and Investigator
|
Up to approximately 2 years
|
|
TTR
Délai: Up to approximately 2 years
|
Time to Response (TTR), as assessed by BICR and Investigator
|
Up to approximately 2 years
|
|
Adverse Event
Délai: Up to approximately 2 years
|
The incidence and severity of AEs, SAEs and AESIs per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0
|
Up to approximately 2 years
|
|
To evaluate the AUC
Délai: Up to approximately 2 years
|
Up to approximately 2 years
|
|
|
To evaluate the Cmax
Délai: Up to approximately 2 years
|
Up to approximately 2 years
|
|
|
To evaluate the Ctrough
Délai: Up to approximately 2 years
|
Up to approximately 2 years
|
|
|
To evaluate the CL
Délai: Up to approximately 2 years
|
Up to approximately 2 years
|
|
|
To evaluate the Vd
Délai: Up to approximately 2 years
|
Up to approximately 2 years
|
|
|
To evaluate the t1/2
Délai: Up to approximately 2 years
|
Up to approximately 2 years
|
|
|
Immunogenicity
Délai: Up to approximately 2 years
|
Incidence of anti-drug antibodies of YL201
|
Up to approximately 2 years
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Tumeurs par site
- Tumeurs
- Tumeurs du système digestif
- Maladies du système digestif
- Tumeurs des glandes endocrines
- Maladies pancréatiques
- Tumeurs pancréatiques
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Enzymes et coenzymes
- Pyrimidines
- Formyltétrahydrofolate
- Tétrahydrofolat
- Acide folique
- Pterines
- Ptéridines
- Uracile
- Pyrimidinones
- Coenzymes
- Fluorouracile
- Leucovorine
- Sucrosofate irinotecan
Autres numéros d'identification d'étude
- TAISHAN-305
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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