A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumours

Titre officiel

A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumours

Sommaire:

Il s’agit d’une étude multicentrique ouverte à doses croissantes et extension de cohortes, visant à évaluer l’innocuité, la tolérabilité, l’activité antitumorale, la pharmacocinétique, la pharmacodynamique et l’immunogénicité du durvalumab (MEDI4736) administré en association avec l’IH2201 chez des sujets adultes présentant certains types de tumeurs solides avancées.

Description de l'essai

Primary Outcome:

  • Occurrence of Drug Limited Toxicities (DLTs)
  • Number of patients with changes in vital signs from baseline
  • Occurrence of adverse events (AEs)
  • Number of patients with changes in electrocariogram (ECG) from baseline
  • Occurrence of serious adverse events (SAEs)
  • Number of patients with changes in laboratory parameters from baseline
  • Objective Response Rate (ORR)
Secondary Outcome:
  • Expression of pre-treatment protein within the tumour microenvironment
  • Number of subjects who develop anti-drug antibodies
  • Durva, monalizumab, biologic agent serum peak concentration (cMax) concentration for Pharmacokinetics
  • Durva and monalizumab serum area under the concentration-time curve (AUC) concentration for Pharmacokinetics
  • Durva and monalizumab serum clearance (CL) concentration for Pharmacokinetics
  • Durva and monalizumab serum terminal elimination half-life (t1/2) concentration for Pharmacokinetics
  • Objective Response Rate (ORR)
  • Progression Free Survival (PFS)
  • Disease Control Rate (DC)
  • Overall Survival (OS)
  • Duration of Response (DoR)
The study consists of 3 parts: dose escalation (Part 1), dose expansion (Part 2), and dose exploration (Part 3). Part 1 will evaluate dose escalation of durvalumab in combination with monalizumab in adult subjects with select advanced solid tumour malignancies. Part 2 will evaluate further the identified dose of durvalumab in combination with monalizumab from Part 1 in adult subjects with select advanced solid tumour malignancies. Part 3 will evaluate dose exploration of durvalumab in combination with monalizumab and standard of care systemic therapy with or without biological agent, and monalizumab in combination with biological agent in adult subjects with CRC.

Voir cet essai sur ClinicalTrials.gov

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