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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
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

NCT04857138

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Solid Tumors

Interventions: RO7300490, Atezolizumab

Countries: Denmark, France, South Korea, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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, 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.
Locations (11)
  • København Ø, Denmark
  • Villejuif, France
  • Seoul, South Korea
  • Seoul, South Korea
  • Pamplona, Navarre, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Edinburgh, United Kingdom
  • London, United Kingdom
  • Manchester, United Kingdom