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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Hoffmann-La Roche
Study ID
NCT03292172
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be given intravenously (IV) at a fixed dose of 1200 mg on Day 1 of each cycle, every 3 weeks.
  • RO6870810 — DRUG
    RO6870810 will be injected SC,at initial planned doses of 0.30, 0.45, or 0.65 mg/kg, QD for the first 14 days of a 21-day cycle.

Study Details

This is Phase IB, open label, non-randomized study designed to investigate the dose, safety, pharmacokinetics and anti-tumor 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.

Key Dates

First listed
Sep 25, 2017
Start date
Nov 8, 2017
Status verified
Nov 2020
Primary completion
Feb 26, 2019
Completion
Feb 26, 2019

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 - Escalation Dose: RO6870810 + Atezolizumab
    Participants will be administered escalating doses of RO6870810 (0.3 milligram per kilogram \[mg/kg\], 0.45 mg/kg, and 0.65 mg/kg) subcutaneously (SC) once daily (QD) along with fixed dose of atezolizumab 1200 mg intravenously (IV) on Day 1 of each cycle (21 day cycles), every 3 weeks. RO6870810 will be given during the first 14 days.
  • Experimental: Group 2 - Sequential Dose: RO6870810 + Atezolizumab
    Participants will be administered RO6870810 monotherapy (starting dose 0.30 mg/kg) during the first 14 days of 21-day Run-in period. Following the Run-in period, participants will continue to receive RO6870810 at the same dose in combination with fixed dose of atezolizumab 1200 mg IV every 3 weeks in 21-day cycles.
  • Experimental: Group 3 - Expansion in TNBC Group: RO6870810 + Atezolizumab
    Participants will be administered dose of RO6870810 established in Group 1 (either 0.3 mg/kg, 0.45 mg/kg, or 0.65 mg/kg) SC QD along with fixed dose of atezolizumab 1200 mg IV on Day 1 of each cycle (21 day cycles), every 3 weeks. RO6870810 will be given during the first 14 days.
  • Experimental: Group 4 - Expansion in OC Group: RO6870810 + Atezolizumab
    Participants will be administered dose of RO6870810 established in Group 1 (either 0.3 mg/kg, 0.45 mg/kg, or 0.65 mg/kg) SC QD along with fixed dose of atezolizumab 1200 mg IV on Day 1 of each cycle (21 day cycles), every 3 weeks. RO6870810 will be given during the first 14 days.

Primary Outcome Measure

Group 1: Percentage of Participants With Dose Limiting Toxicities (DLT) [ Time Frame: Cycle 1 (Day 21) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Oklahoma University Health Sciences CenterOklahoma CityOklahoma73104-
Sarah Cannon Res Inst; TN OncNashvilleTennessee37203-

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OncologyBreast oncologyWomen's health
By research site
Dana Farber Cancer Institute· Boston, MAOklahoma University Health Sciences Center· Oklahoma City, OKSarah Cannon Res Inst; TN Onc· Nashville, TN

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