A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors

July 10, 2026 updated by: Hoffmann-La Roche

An Open-label, Multicenter, Dose-escalation, Randomized, Phase I Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Anti-Tumor Activity of RO7567132, as a Single Agent and in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab. The study will enroll adult participants with selected locally advanced and/or metastatic solid tumors for whom standard therapy does not exist, or has proven to be ineffective or intolerable.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Kinghorn Cancer Centre
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer ? Vancouver
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Center
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Center
  • Denmark
      • København Ø, Denmark, 2100
        • Rigshospitalet
  • Spain
      • Barcelona, Spain, 08035
        • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28027
        • Clinica Universidad de Navarra Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female participants aged ≥18 years
  • Body weight > 40 kilograms (kg)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and Life expectancy of at least 12 weeks
  • Participants with advanced and/or metastatic solid tumors
  • Availability and willingness to provide a mandatory archival tumor specimen or (if not available) a fresh baseline biopsy
  • Negative serum pregnancy test
  • Participants must have adequate cardiovascular, hematological, liver and renal function.

Exclusion Criteria:

  • Known central nervous system (CNS) tumors or metastases and leptomeningeal metastases
  • Active second malignancy within 2 years prior to screening
  • History or current clinically significant cardiovascular/cerebrovascular disease
  • Active or history of autoimmune disease
  • Serious, uncontrolled infection
  • Known clinically significant liver disease
  • Unresolved acute toxicity > grade 1 from prior therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part I: RO7567132 Dose Escalation With or Without Atezolizumab
Drug: RO7567132 and Atezolizumab
RO7567132 will be administered either as monotherapy or in combination with atezolizumab at a dose and schedule as specified for the respective cohort.
Drug: RO7567132 and Atezolizumab
RO7567132 will be administered in combination with atezolizumab at a dose and schedule as specified for the respective cohort.
Experimental: Part II: RO7567132 Backfill With Atezolizumab
Drug: RO7567132 and Atezolizumab
RO7567132 will be administered either as monotherapy or in combination with atezolizumab at a dose and schedule as specified for the respective cohort.
Drug: RO7567132 and Atezolizumab
RO7567132 will be administered in combination with atezolizumab at a dose and schedule as specified for the respective cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Time Frame: Up to a maximum of 27 months
Up to a maximum of 27 months
Percentage of Participants With Dose-limiting Toxicities (DLTs)
Time Frame: From baseline to 3 weeks on study
From baseline to 3 weeks on study

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum Concentration (Cmax) Derived for RO7567132
Time Frame: Up to a maximum of 24 months
Up to a maximum of 24 months
Time of Maximum Concentration (Tmax)
Time Frame: Up to a maximum of 24 months
Up to a maximum of 24 months
Minimum Concentration (Cmin)
Time Frame: Up to maximum of 24 Months
Up to maximum of 24 Months
Clearance (CL) or Apparent Clearance (CL/F)
Time Frame: Up to a maximum of 24 months
Up to a maximum of 24 months
Volume of Distribution at Steady State (Vss)
Time Frame: Up to a maximum of 24 months
Up to a maximum of 24 months
Area Under the Curve (AUC) for Various Time Intervals
Time Frame: Up to a maximum of 24 months
Up to a maximum of 24 months
Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7567132
Time Frame: Up to 24 months
Up to 24 months
Objective Response Rate (ORR)
Time Frame: Up to a maximum of 24 months
Up to a maximum of 24 months
Disease Control Rate (DCR)
Time Frame: Up to a maximum of 24 months
Up to a maximum of 24 months
Duration of Response (DoR)
Time Frame: Up to a maximum of 24 months
Up to a maximum of 24 months
Progression Free Survival (PFS)
Time Frame: Up to a maximum of 24 months
Up to a maximum of 24 months
Overall Survival (OS)
Time Frame: Up to a maximum of 24 months
Up to a maximum of 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical trails, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Estimated)

May 12, 2027

Study Completion (Estimated)

August 10, 2027

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP44956
  • 2024-512839-70-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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