A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.

NCT ID: NCT04642365

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2024-01-04

Brief Summary

This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.

Conditions

Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part I

Dose-Escalation: Mixed solid tumors participants will receive ascending doses of RO7296682 with a fixed dose of Atezolizumab, every three weeks (Q3W) until either the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) is defined.

Group Type: EXPERIMENTAL

RO7296682

Intervention Type: DRUG

RO7296682 will be administered as per the schedules specified in the respective arms.

Atezolizumab

Intervention Type: DRUG

Atezolizumab will be administered as per the schedules specified in the respective arms.

Part II

Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I. Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab.

Group Type: EXPERIMENTAL

RO7296682

Intervention Type: DRUG

RO7296682 will be administered as per the schedules specified in the respective arms.

Atezolizumab

Intervention Type: DRUG

Atezolizumab will be administered as per the schedules specified in the respective arms.

Part III (Exploratory)

Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I and if clinical activity is seen in this trial or in the single agent study (WP41188). Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab at the dosing regimen established in Part I.

Group Type: EXPERIMENTAL

RO7296682

Intervention Type: DRUG

RO7296682 will be administered as per the schedules specified in the respective arms.

Atezolizumab

Intervention Type: DRUG

Atezolizumab will be administered as per the schedules specified in the respective arms.

Interventions

RO7296682

RO7296682 will be administered as per the schedules specified in the respective arms.

Intervention Type: DRUG

Atezolizumab

Atezolizumab will be administered as per the schedules specified in the respective arms.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of advanced and/or metastatic solid tumors who have progressed on a standard therapy, are intolerant to standard of care (SoC), and/or and non-amenable to SoC.

Participants whose tumors have known sensitizing mutations must have experienced disease progression (during or after treatment) or intolerance to treatment with a respective targeted therapy.

• Measurable disease according to RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Able to provide the most recent archival tumor tissue samples.
• Adequate cardiovascular, haematological, liver and renal function.
• Participants on therapeutic anticoagulation must be on a stable anticoagulant regimen.
• Women of Childbearing Potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
• Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm.

Exclusion Criteria

• Pregnancy, lactation, or breastfeeding.
• Known hypersensitivity to any of the components of RO7296682 and atezolizumab, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
• History or clinical evidence of central nervous system (CNS) primary tumors or metastases.
• Participants with another invasive malignancy in the last two years.
• Participants with known active or uncontrolled infection.
• Positive HIV test at screening.
• Positive for Hepatitis B and C.
• Vaccination with live vaccines within 28 days prior to C1D1.
• Major surgical procedure or significant traumatic injury within 28 days prior to first RO7296682 and atezolizumab infusion.
• Participants with wound healing complications.
• Dementia or altered mental status that would prohibit informed consent.
• History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS (drug rash with eosinophilia and systemic symptoms).
• Active or history of autoimmune disease or immune deficiency.
• Prior treatment with CPIs (e.g. anti-CTLA4, anti-PD1, anti-PDL1), immunomodulatory monoclonal antibodies (mAbs) and/or mAb-derived therapies (approved or investigational) is approved.
• Treatment with standard radiotherapy, any chemotherapeutic agent, targeted therapy or treatment with any other investigational drug (defined as treatment for which there is currently no regulatory authority-approved indication) within 28 days or 5 half-lives of the drug (whichever is shorter), prior to the first RO7296882 administration on C1D1.
• Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy (for which no wash out period is required).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Peter Maccallum Cancer Institute

Melbourne, Victoria, Australia

Cliniques Universitaires St-Luc

Brussels, , Belgium

BC Cancer Agency - Vancouver

Vancouver, British Columbia, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Rigshospitalet

København Ø, , Denmark

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

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

Barcelona, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Countries

United States; Australia; Belgium; Canada; Denmark; Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020-003164-82

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP42595

Identifier Type: -

Identifier Source: org_study_id