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

Official Title

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

Summary:

This is a multicentre, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumour activity, PK, pharmacodynamics, and immunogenicity of Durvalumab (MEDI4736) in combination with monalizumab (IPH2201) in Adult Subjects with selected advanced solid tumours and the combination of durvalumab and monalizumab (IPH2201) standard of care systemic therapy with or without biological agent and monalizumab (IPH2201) with biological agent administered to subjects with recurrent or metastatic colorectal cancer (CRC).

Trial Description

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 PD-L1 and HLA-E.
  • 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society