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NCT05086692Recrutement en cours

A Beta-only IL-2 ImmunoTherapY Study

Résumé

This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.

Critères d'inclusion

1. Aged at least 18 years (inclusive at the time of informed consent). 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. 3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures. 4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions) 5. Demonstrated adequate organ function 6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and/or MRI. 7. Life expectancy of ≥ 12 weeks. 8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding. 9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.

Critères d'exclusion

1. Last administration of prior antitumor therapy: • Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment. • Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\<2 weeks of radiotherapy) to non-CNS disease. • Radiation therapy to the lung that is \> 30Gy within 6 months prior to start of treatment. • Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval. 2. Has known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM. 3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers. 4. Condition requiring long-term systemic treatment with either corticosteroids \> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment. 5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy. 6. Severe pulmonary, cardiac or other systemic disease. 7. Known hepatitis B or C virus infection. 8. Females who are pregnant or lactating or planning to become pregnant during the study. 9. Has had an allogeneic tissue/solid organ transplant. 10. Active infection requiring systemic therapy. 11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol 12. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events. 13. Known severe hypersensitivity to any component of study drug(s). 14. Inability to comply with study and follow up procedures as judged by the Investigator.

Contacts

Les coordonnées de l'équipe de l'essai s'affichent sur demande.

Voir la fiche officielle de l'essai
Statut
Recrutement en cours
Phase
Phase 1 · Phase 2
Type d'étude
Interventionnelle
Pays
Suisse, États-Unis, Australie, Canada, Irlande, Portugal, Corée du Sud, Espagne
Promoteur
Medicenna Therapeutics, Inc.(Industrie)
N° de protocole
MDNA11-01
Pathologies
Advanced Solid Tumor, Unresectable Solid Tumor, Clear Cell Renal Cell Carcinoma, Triple Negative Breast Cancer, Non-Small Cell Lung Cancer Squamous, Non-Small Cell Lung Cancer Non-squamous, Colorectal Cancer (MSI-H), Gastric Cancer, Cervical Cancer, Basal Cell Carcinoma, Bladder Cancer, Merkel Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Cutaneous Squamous Cell Carcinoma, Pleural Mesothelioma, Esophageal Cancer, Endometrial Carcinoma, Solid Tumor, Solid Tumor, Adult, MSI-H Solid Malignant Tumor, Cancer With A High Tumor Mutational Burden, Epithelial Ovarian Carcinoma, Primary Peritoneal Cancer, Gastroesophageal Junction (GEJ) Cancer, Acral Melanoma, Mucosal Melanoma, Cutaneous Melanoma, DMMR Solid Malignant Tumor, Fallopian Tube Cancer, Ovarian Cancer, MSI-H Cancer, DMMR Cancer, Pancreas Adenocarcinoma (MSI-H), Skin Cancer, Viral Cancer, Cervical Cancers, Endometrial Cancer
Interventions
Médicament

Traitements évalués

  • MDNA11
  • Pembrolizumab (KEYTRUDA®)

Collaborateurs

Merck Sharp & Dohme LLC

Lieux · 11

  • Zurich, SuisseHautkrebszentrum, Dermatologische Klinik Universitätsspital ZürichRecrute dans ce centre
  • Greenslopes, AustralieGallipoli Medical Research FoundationRecrute dans ce centre
  • Dublin, IrlandeMater Misericordiae University HospitalRecrute dans ce centre
  • Lisbon, PortugalSTART Lisbon - Centro de Ensaios Clínicos, ULS Sta MariaRecrute dans ce centre
  • Porto, PortugalInstituto Portugues De Oncologia Do PortoRecrute dans ce centre
  • Badalona, EspagneInstitut Catala d'Oncologia (ICO)-BadalonaRecrute dans ce centre
  • Barcelona, EspagneSTART Barcelona / HM Nou DelfosRecrute dans ce centre
  • Madrid, EspagneHospital Universitario Ramón y CajalRecrute dans ce centre
  • Madrid, EspagneSTART Madrid / Hospital Universitario Fundacion Jimenez DiazRecrute dans ce centre
  • Madrid, EspagneHospital Universitario Hm SanchinarroRecrute dans ce centre
  • Torrejón, EspagneHospital Universitario de TorrejonRecrute dans ce centre

Au total, dans le monde, 11 des 28 centres listés au registre recrutent ; les 17 autres ne recrutent pas actuellement.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 13 octobre 2026).

Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.

Autres identifiants

  • KEYNOTE-E53 · autre identifiant
  • MK3475-E53 · autre identifiant
  • 2023-507536-21-00 · n° CTIS
  • 2023 · financement NIH

Voir aussi

Autres versions

Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.