A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2026-08-17
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate the safety, pharmacokinetics and anti-tumor activity of RO7300490 as a single agent or in combination with atezolizumab. The study will consist of 3 parts: [Part 1] Dose-Escalation of RO7300490 as a single agent; [Part 2] Dose-Escalation of RO7300490 in combination with atezolizumab and [Part 3] Dose-Expansion of RO7300490 in combination with atezolizumab in selected cancer types.

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

Details

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

Criteria

Inclusion Criteria:

• Life expectancy of >= 12 weeks.

• Histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors that are not amenable to standard therapy.

• Radiologically measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

• Agreement to provide protocol-specific biopsy material.

• Adverse Events (AEs) from prior anti-cancer therapy resolved to Grade =<1.

• Adequate performance status and cardiovascular, hematological, liver, renal and coagulation function.

• For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs.

• For male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.

Exclusion Criteria:

• Known central nervous system (CNS) primary tumors or metastases, including leptomeningeal metastases.

• Active second malignancy requiring anticancer treatment and/or palliative supportive care.

• Significant cardiovascular/cerebrovascular disease within 6 months prior to study treatment start.

• Any other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding that gives reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug.

• Prior allogeneic bone marrow transplantation or prior solid organ transplantation.

• Active or history of autoimmune disease.

• Known hypersensitivity to any of the components of RO7300490 formulation or to components of atezolizumab formulation.

• Pregnancy, lactation or breastfeeding.

• Dementia or altered mental status that would prohibit informed consent.

• Major surgery or significant traumatic injury within 28 days prior to the first study drug administration (excluding biopsies) or anticipation of the need for major surgery during study treatment.

• Treatment with radiotherapy, chemotherapy, hormonal therapy, targeted therapy, immunotherapy or investigational drug concurrent or within 28 days or 5 half-lives of the drug (whichever is shorter) before the first study drug administration.