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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
- Cancer
- Solid Tumors
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Countries
- Denmark
- France
- South Korea
- Spain
- United Kingdom
Trial Identifier:
NCT04857138 2020-004489-21 WP42627
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT04857138,WP42627,2020-004489-21
Trial Identifier
RO7300490, Atezolizumab
Treatments
Solid Tumors
Condition
Official Title
An Open-Label, Multicenter, Dose-Escalation and Expansion, Phase I Study to Evaluate Safety, Pharmacokinetics, And Anti-Tumor Activity of RO7300490, A Fibroblast Activation Protein-α (FAP) Targeted CD40 Agonist, as Single Agent or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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, unless protocol-specific conditions are met.
- Active second invasive malignancy within two years prior to screening.
- 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.
For the latest version of this information please go to www.forpatients.roche.com