Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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-Escalati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04857138
Start Date
May 18 2021
End Date
January 18 2024
Last Update
February 5 2024
Active Locations (11)
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1
Rigshospitalet; Fase 1 Enhed - Onkologi
København Ø, Denmark, 2100
2
Gustave Roussy
Villejuif, France, 94805
3
Seoul National University Hospital
Seoul, South Korea, 03080
4
Asan Medical Center
Seoul, South Korea, 05505