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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Fundación Jiménez Díaz
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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