A Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RO6870810 and Atezolizumab (PD-L1 Antibody) in Participants With Advanced Ovarian Cancer or Triple Negative Breast Cancer

Official Title

Open Label, Dose Finding and Expansion Phase IB Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RO6870810 and Atezolizumab (Pd L1 Antibody) in Pateints With Advanced Ovarian Cancer or Triple Negative Breast Cancer

Summary:

This is Phase IB, open label, non-randomized study designed to investigate the dose, safety, pharmacokinetics and anti-tumour activity of RO6870810 in combination with a fixed dose of atezolizumab. The study consists of four groups, Group 1 (Dose Escalation Group) and Group 2 (Sequential Dose Group), and Groups 3 and 4 (Expansion Groups), which will further evaluate the safety, pharmacokinetic, pharmacodynamic and preliminary clinical activity in patients with triple negaive breast cancer and/or ovarian cancer.

Trial Description

Primary Outcome:

  • Group 1: Percentage of Participants With Dose Limiting Toxicities (DLT)
  • Groups 1 to 4: Percentage of Participants With Adverse Events (AEs)
  • Groups 1 to 4: Percentage of Participants With Change in Vital Signs, Physical Findings, Electrocardiogram (ECG) and Laboratory Parameters
  • Groups 3 and 4: Objective Response (OR) as per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Secondary Outcome:
  • Groups 1 to 4: Maximum concentration (Cmax) of RO6870810 (RO) and Atezolizumab (Ate)
  • Groups 1 to 4: Time of maximum concentration (tmax) of RO6870810 and Atezolizumab
  • Groups 1 to 4: Clearance (CL) or Apparent Clearance (CL/F) of RO6870810 and Atezolizumab
  • Groups 1 to 4: Volume of Distribution (Vd) or Apparent Volume of Distribution (Vd/F) of RO6870810 and Atezolizumab
  • Groups 1 to 4: Area Under the Plasma Concentration-Time Curve From Time Zero to End of the Dosing Interval (AUC0-tau) of RO6870810 and Atezolizumab
  • Groups 1 to 4: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of RO6870810 and Atezolizumab
  • Groups 1 to 4: Half life (t1/2) of RO6870810 and Atezolizumab
  • Groups 1 to 4: Trough concentration (Ctrough) of RO6870810 and Atezolizumab
  • Groups 1 and 2: Objective Response (OR) as per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
  • Groups 1 to 4: Objective Response (OR) as per Immune-Modified RECIST
  • Groups 1 to 4: Duration of Response (DoR) as per RECIST v1.1 and Immune-Modified RECIST
  • Groups 1 to 4: Progression-Free Survival (PFS) per RECIST v1.1 and Immune-Modified RECIST
  • Groups 1 to 4: Overall Survival (OS)
  • Groups 1 to 4: Tumour Marker Assessments (CA-125, According to Modified Gynecologic Cancer InterGroup [GCIG] Guidelines,CEA, CA15-3 Changes)
  • Groups 1 to 4: Changes in CD11b Expression Levels Measurement in CD14+ Monocytes From Blood Association with Steady-State RO6870810 PK Drug Exposure
  • Groups 1 to 4: Changes in Markers (e.g., PD-L1, CD8/Ki 67) in Tissue Biopsy Specimens by Immunohistochemistry (IHC)
  • Groups 1 to 4: Groups 1 to 4: Percentage of Participants With Transcript Profiling Assessment Receiving Combination Study Treatment

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