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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Atezolizumab

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).