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

NCT ID: NCT06537310

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2029-06-19

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer-Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part I: RO7567132 Dose Escalation With or Without Atezolizumab

Group Type EXPERIMENTAL

RO7567132 and Atezolizumab

Intervention Type DRUG

RO7567132 will be administered either as monotherapy or in combination with atezolizumab at a dose and schedule as specified for the respective cohort.

Part II: RO7567132 Backfill With Atezolizumab

Group Type EXPERIMENTAL

RO7567132 and Atezolizumab

Intervention Type DRUG

RO7567132 will be administered in combination with atezolizumab at a dose and schedule as specified for the respective cohort.

Interventions

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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.

Intervention Type DRUG

RO7567132 and Atezolizumab

RO7567132 will be administered in combination with atezolizumab at a dose and schedule as specified for the respective cohort.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical trails

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Brown University Health

Providence, Rhode Island, United States

Site Status

SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status

Kinghorn Cancer Centre

Darlinghurst, New South Wales, Australia

Site Status

Austin Health

Heidelberg, Victoria, Australia

Site Status

UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status

BC Cancer ? Vancouver

Vancouver, British Columbia, Canada

Site Status

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Site Status

McGill University Health Center

Montreal, Quebec, Canada

Site Status

Rigshospitalet

København Ø, , Denmark

Site Status

Centre Leon Berard

Lyon, , France

Site Status

Institut Claudius Regaud

Toulouse, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Site Status

Vall d?Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, , Spain

Site Status

Clinica Universidad de Navarra Madrid

Madrid, , Spain

Site Status

Fundacion Jimenez Diaz

Madrid, , Spain

Site Status

Countries

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United States Australia Belgium Canada Denmark France Spain

Other Identifiers

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2024-512839-70-00

Identifier Type: OTHER

Identifier Source: secondary_id

BP44956

Identifier Type: -

Identifier Source: org_study_id