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

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: Cancer-Neoplasms
• Intervention / Treatment: Drug: RO7567132 and Atezolizumab; Drug: RO7567132 and Atezolizumab

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

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
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad de Navarra

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	Up to a maximum of 27 months
Percentage of Participants With Dose-limiting Toxicities (DLTs)	From baseline to 3 weeks on study

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical trails, Hoffmann-La Roche

Study record dates

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): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; atezolizumab
• 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