A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.
- Cancer
- Solid Tumors
Completed
- Barcelona
- Bruxelles
- Houston
- København
- Madrid
- Melbourne
- Ottawa
- Pamplona
- Toronto
- València
- Vancouver
NCT04642365 2020-003164-82 BP42595
Trial 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.
An Open-Label, Multicenter, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of RO7296682 in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
Eligibility 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.
- 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).
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