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Une étude de première humaine de YL217 chez les patients atteints de tumeurs solides avancées

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

Une étude de phase 1, multicentrique, ouverte, premier à l'humain pour évaluer la sécurité, la tolérabilité, la pharmacocinétique et l'efficacité de YL217 chez les patients atteints de tumeurs solides avancées

A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

YL217 is an antibody-drug conjugate (ADC) that targets CDH17 (Cadherin-17) protein and is being developed for the treatment of cancer. YL217 is comprised of three components: 1) YL217-mAb, a CDH17-targeting recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody, 2) YL0010014, a topoisomerase I inhibitor, and 3) an enzymatically cleavable methylsulfonyl pyrimidine tripeptide drug linker.

The in vivo anti-tumor efficacy of YL217 was evaluated in immune-deficient mice bearing human colorectal cancer, gastric cancer and patient derived colorectal cancer xenograft tumors. The results indicated that YL217 was well tolerated, and YL217 suppressed growth of established human tumors in a dose-dependent manner in cancer cells or patient derived xenograft models.

Therefore, in order to meet the huge unmet medical needs in the field of gastrointestinal cancer treatment, it is planned to conduct the first human phase I clinical study of YL217 in patients with advanced solid tumors.

Type d'étude

Interventionnel

Inscription (Estimé)

630

Phase

  • La phase 1

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

  • Chine
    • Bejing
      • Beijing, Bejing, Chine, 100730
        • Recrutement
        • Peking Union Medical College Hospital
        • Contact:
          • Study Coordinator
    • Guangdong
      • Guangzhou, Guangdong, Chine, 510655
        • Pas encore de recrutement
        • The Sixth Affiliated Hospital of Sun Yat-sen University
    • Heilongjiang
      • Harbin, Heilongjiang, Chine, 150081
        • Recrutement
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Study Coordinator
    • Jiangxi
      • Nanchang, Jiangxi, Chine, 330006
        • Pas encore de recrutement
        • The First Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyang, Liaoning, Chine, 110001
        • Pas encore de recrutement
        • The First Affiliated Hospital of China Medical University
    • Shandong
      • Jinan, Shandong, Chine, 250117
        • Recrutement
        • Cancer Hospital of Shandong First Medical University
        • Contact:
          • Study Coordinator
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200025
        • Recrutement
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
          • Study Coordinator
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Chine, 300060
        • Recrutement
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Study Coordinator
    • Zhejiang
      • Hangzhou, Zhejiang, Chine, 310022
        • Recrutement
        • Zhejiang Cancer Hospital
        • Contact:
          • Study Coordinator
  • États-Unis
    • Arizona
      • Phoenix, Arizona, États-Unis, 85054
        • Recrutement
        • Mayo Clinic Arizona
        • Contact:
          • Study Coordinator
    • California
      • Santa Monica, California, États-Unis, 90404
        • Recrutement
        • UCLA Hematology/Oncology - Santa Monica
        • Contact:
          • Study Coordinator
    • Connecticut
      • New Haven, Connecticut, États-Unis, 06519
        • Recrutement
        • Yale Cancer Center
    • Kansas
      • Kansas City, Kansas, États-Unis, 66205
        • Recrutement
        • The University of Kansas Cancer Center (KUCC)
        • Contact:
          • Study Coordinator
    • Michigan
      • Detroit, Michigan, États-Unis, 48201
        • Recrutement
        • Karmanos Cancer Institute
        • Contact:
          • Study Coordinator
    • New York
      • New York, New York, États-Unis, 10032
        • Recrutement
        • Columbia University Irving Medical Center
        • Contact:
          • Study Coordinator
    • North Carolina
      • Durham, North Carolina, États-Unis, 27710
        • Recrutement
        • Duke University Medical Center (DUMC)
        • Contact:
          • Study Coordinator
    • Ohio
      • Cincinnati, Ohio, États-Unis, 45219
        • Recrutement
        • University of Cincinnati Medical Center
        • Contact:
          • Study Coordinator
      • Cleveland, Ohio, États-Unis, 44195
        • Recrutement
        • Cleveland Clinic Taussig Cancer Institute
        • Contact:
          • Study Coordinator
    • Texas
      • Houston, Texas, États-Unis, 77030
        • Recrutement
        • The University of Texas MD Anderson Cancer Center
        • Contact:
          • Study Coordinator
      • San Antonio, Texas, États-Unis, 78229
        • Recrutement
        • UT Health San Antonio - Mays Cancer Center
        • Contact:
          • Study Coordinator
    • Wisconsin
      • Madison, Wisconsin, États-Unis, 53792
        • Recrutement
        • University of Wisconsin Health - UW Carbone Cancer Center
        • 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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Informed of the study before the start of the study and voluntarily sign their name and date in the ICF
  • Able and willing to comply with protocol visits and procedures
  • Age≥ 18 years
  • ECOG PS of 0 or 1
  • Pathologically confirmed diagnosis of an advanced solid tumor. For CRC cohorts: : Histologically or cytologically documented locally advanced unresectable or metastatic colorectal carcinoma that is not eligible for curative surgery and/or definitive chemoradiotherapy
  • Adequate organ and bone marrow function.
  • Have at least 1 extracranial measurable tumor lesion.
  • Adequate archival formalin-fixed paraffin embedded （FFPE） tissue from prior biopsy.

Exclusion Criteria:

  • Prior treatment with an agent targeting CDH17
  • Prior discontinuation of a topoisomerase I inhibitor due to treatment-related toxicities.
  • Have received an ADC consisting of a topoisomerase I inhibitor.
  • Concurrent enrollment in another clinical study, unless it is an observational clinical study.
  • Inadequate washout period for prior anticancer treatment before the first dose of study drug
  • Undergone major surgery within 4 weeks before the first dose of study drug or expect major surgery during the study, minor procedures (e.g., core needle biopsy, superficial biopsy) within 7 days before the first dose of study drug.
  • Received long term systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug.
  • Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study.
  • Diagnosis or evidence of spinal cord compression or leptomeningeal carcinomatosis.
  • Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
  • A history of non-infectious interstitial lung disease (ILD)/pneumonitis that requires steroids, current active ILD/pneumonitis.
  • Have clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
  • Uncontrolled third-space fluid that requires repeated drainage.
  • Digestive system disease that may cause bleeding, perforation, jaundice, fistula, GI obstruction within 6 months prior to the first dose of study drug administration or have active inflammatory bowel disease.
  • An active tuberculosis based on medical history.
  • Known human immunodeficiency virus (HIV) infection.
  • Active hepatitis C infection.

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: Non randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Combo-Dose Escalation,Backfill and Expansion

Participants will receive YL217 in combination of bevacizumab with or without 5-FU/LV
Médicament: YL217

Patients will receive specific dose of YL217 administered via intravenous(IV)infusion.

Médicament: Bevacizumab

Participants will receive bevacizumab administered via intravenous(IV) infusion,at 5mg/kg,Q2W.

Médicament: 5-FU with leucovorin

Participants will receive 5 fluorouracil 2400mg/m2 and leucovorin 400mg/m2, administered via intravenous (IV) infusion, Q2W
Expérimental: Mono-Dose Escalation,Backfill and Expansion

Participants will receive YL217 monotherapy
Médicament: YL217

Patients will receive specific dose of YL217 administered via intravenous(IV)infusion.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Nature and frequency of dose-limiting toxicity(DLT)
Délai: Up to approximately 3 years

The purpose of DLT is to find maximum tolerated dose (MTD).
Up to approximately 3 years
Nature and frequency of adverse events (AEs) with severity
Délai: Up to approximately 3 years

Nature and frequency of AEs with severity is aim to evaluate the safety of YL217.
Up to approximately 3 years
objective response rate (ORR)
Délai: Up to approximately 3 years

ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).
Up to approximately 3 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pour évaluer le critère de sécurité de la saturation en oxygène périphérique (SPO2)
Délai: Jusqu'à environ 3 ans
Jusqu'à environ 3 ans
Eastern Cooperative Oncology Group performance status (ECOG PS)
Délai: Up to approximately 3 years

Deterioration of Eastern Cooperative Oncology Group performance status (ECOG PS)
Up to approximately 3 years
Characterize Pharmacokinetics(PK) parameter AUC
Délai: Up to approximately 3 years

The area under curve: AUC is the total amount of YL217 in bloodstream after drug administration.
Up to approximately 3 years
Characterize Pharmacokinetics(PK) parameter Cmax
Délai: Up to approximately 3 years

Maximum concentration：The highest measured concentration of YL217 in the bloodstream.
Up to approximately 3 years
Characterize Pharmacokinetics(PK) parameter Ctrough
Délai: Up to approximately 3 years

Trough concentration
Up to approximately 3 years
Characterize Pharmacokinetics(PK) parameter Tmax
Délai: Up to approximately 3 years

Time to maximum observed concentration
Up to approximately 3 years
Characterize Pharmacokinetics(PK) parameter CL
Délai: Up to approximately 3 years

Clearance： defined as the amount of drug removed from the bloodstream by the body per unit of time.
Up to approximately 3 years
Characterize Pharmacokinetics(PK) parameter Vd
Délai: Up to approximately 3 years

volume of distribution
Up to approximately 3 years
Characterize Pharmacokinetics(PK) parameter t1/2
Délai: Up to approximately 3 years

Half-life time：defined as the time it takes for the concentration of the drug in plasma or serum to be reduced by 50%.
Up to approximately 3 years
Immunogenicity endpoint: Incidence of anti-YL217 antibody (ADAs).
Délai: Up to approximately 3 years

The presence of ADAs in patients treated with YL217 will be assessed to evaluate immunogenicity.
Up to approximately 3 years
Disease control rate (DCR)
Délai: Up to approximately 3 years

DCR: defined as the proportion of patients who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD).
Up to approximately 3 years
Duration of response (DoR)
Délai: Up to approximately 3 years

DoR: defined as the time interval from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease (PD).
Up to approximately 3 years
Time to response (TTR)
Délai: Up to approximately 3 years

TTR: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of objective response (CR or PR).
Up to approximately 3 years
Depth of response (DpR)
Délai: Up to approximately 3 years

DpR: defined as the proportion of target lesion shrinkage from baseline to maximum tumor size.
Up to approximately 3 years
Progression-free survival (PFS)
Délai: Up to approximately 3 years

PFS: defined as the time interval from the date of the first dose of study drug to the date of first documentation of PD or death due to any cause, whichever occurs first.
Up to approximately 3 years
Overall survival (OS)
Délai: Up to approximately 3 years

OS: defined as the time interval from the date of the first dose of study drug to the date of death due to any cause.
Up to approximately 3 years

Collaborateurs et enquêteurs

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

Parrainer

MediLink Therapeutics (Suzhou) Co., Ltd.

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 (Réel)

2 juillet 2025

Achèvement primaire (Estimé)

1 juillet 2028

Achèvement de l'étude (Estimé)

1 juillet 2030

Dates d'inscription aux études

Première soumission

18 février 2025

Première soumission répondant aux critères de contrôle qualité

4 mars 2025

Première publication (Réel)

5 mars 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • YL217-INT-101-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

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

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

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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