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A Trial of Ipatasertib in Combination With Atezolizumab

NCT03673787 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2025-05-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

ipatasertib

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.

DRUG

Atezolizumab

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.

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Juanita Lopez, MRCP · National Health Service, United Kingdom

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-13
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • United Kingdom

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03673787 on ClinicalTrials.gov