A Study of Durvalumab (MEDI4736) and IPH2201 in Solid Tumours

Official Title

A Phase 1 Study of Durvalumab and IPH2201 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 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
Secondary Outcome:
  • Biomarkers predicting expression of PD-L1 and HLA-E.
  • Number of subjects who develop anti-drug antibodies
  • Durva and monalizumab 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
  • Overall Survival (OS)
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 standard of care systemic therapy with or without biological agent in adult subjects with CRC.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society