A Trial of Ipatasertib in Combination With Atezolizumab

Sponsor
Institute of Cancer Research, United Kingdom
Study ID
NCT03673787
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Glioblastoma Multiforme
  • Prostate Cancer Metastatic
  • Solid Tumor

Eligibility Criteria

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

Interventions

  • ipatasertib — DRUG
    Ipatasertib will be supplied as film-coated tablets in two strengths (100 and 200 mg) differentiated by size, shape, and weight of tablets. Ipatasertib tablets are packaged in high-density polyethylene bottles with desiccant.
  • Atezolizumab — DRUG
    Atezolizumab will be supplied as a single-use 20 mL USP/Ph. Eur Type 1 glass vial as a colourless-to-slightly-yellow, sterile, preservative-free clear liquid solution intended for intravenous (IV) administration.

Study Details

This is a single centre, proof-of-concept phase I trial of atezolizumab in combination with ipatasertib. There are two parts to this study, the dose escalation phase (Part A) and the dose expansion phase (Part B). Part A, will determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). This will be followed by the Part B dose expansion phase to further characterise the safety and tolerability and to assess the pharmacodynamic activity of the combination.

Key Dates

Start date
Aug 13, 2018
Status verified
May 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
87 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Phase I
    Increasing doses of ipatasertib in combination with a fixed dose of atezolizumab to establish the recommended phase II dose.
  • Experimental: Phase II
    The Phase II part of the study will evaluate the recommended phase II dose of ipatasertib identified in Phase I, in combination with atezolizumab, in six patient cohorts: patients with solid tumours who have hyperactivation of the PI3K pathway; patients with castrate-resistant prostate cancer with PTEN loss; patients with glioblastoma; patients with melanoma; patients solid tumour types refractory to immune-checkpoint inhibitors; patients with gynaecological cancers.

Primary Outcome Measure

To identify a maximum tolerated dose in Phase I [ Time Frame: 12 months ]

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