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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

2 septembre 2026 mis à jour par: MediLink Therapeutics (Suzhou) Co., Ltd.

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

The purpose of this study is to evaluate the safety and efficacy of an investigational B7-H3 antibody drug-conjugate administered as monotherapy, compared with standard of care (SOC) chemotherapy in metastatic pancreatic cancer patients who have failed prior Gemcitabine-based systemic therapy.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Estimé)

320

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200127
        • Shanghai Jiaotong University School of Medicine
        • Contact:
          • Study Coordinator

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Participants must voluntarily sign a written informed consent form (ICF) and be willing and able to comply with protocol requirements.
  2. Participants must be ≥18 and ≤75 years of age.
  3. Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
  4. Participants must have a life expectancy of at least 3 months.
  5. Participants must have histologically or cytologically confirmed incurable metastatic pancreatic ductal adenocarcinoma (PDAC).
  6. Participants must have received and failed only one prior line of gemcitabine-based systemic therapy.
  7. Participants must have at least one measurable lesion according to RECIST v1.1.
  8. Participants must have adequate organ function as defined in the protocol.
  9. Participants must agree to follow the contraception requirements specified in the protocol.

Exclusion Criteria:

  1. Participants with another malignancy within 5 years before randomization.
  2. Participants with pathologically confirmed pancreatic cancer other than PDAC.
  3. Participants who have previously received B7-H3-targeted therapy.
  4. Participants who have previously received topoisomerase I inhibitor or antibody-drug conjugate containing topoisomerase I inhibitor.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. Participants with unresolved toxicity from prior anticancer therapy that has not recovered to the level specified in the protocol.
  11. Participants with known hypersensitivity to any component of the study treatment, or a history of severe hypersensitivity reactions or severe infusion-related reactions.
  12. 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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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:
  • YL201, Tam-Peli
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

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 janvier 2029

Achèvement de l'étude (Estimé)

1 mai 2029

Dates d'inscription aux études

Première soumission

31 août 2026

Première soumission répondant aux critères de contrôle qualité

2 septembre 2026

Première publication (Réel)

4 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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