Phase
Condition
Neoplasms
Solid Tumors
Treatment
Atezolizumab
RO7300490
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Life expectancy of >= 12 weeks.
- Histologically confirmed diagnosis of locally advanced and/or metastatic solid tumorsthat are not amenable to standard therapy.
- Radiologically measurable disease as defined by Response Evaluation Criteria in SolidTumors (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 andcoagulation function.
- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain fromdonating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexualintercourse), use contraceptive measures and refrain from donating sperm.
Exclusion
Exclusion Criteria:
- Known central nervous system (CNS) primary tumors or metastases, includingleptomeningeal 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 studytreatment start.
- Any other diseases, metabolic dysfunction, physical examination finding or clinicallaboratory finding that gives reasonable suspicion of a disease or condition thatwould 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 tocomponents 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 studydrug administration (excluding biopsies) or anticipation of the need for major surgeryduring study treatment.
- Treatment with radiotherapy, chemotherapy, hormonal therapy, targeted therapy,immunotherapy or investigational drug concurrent or within 28 days or 5 half-lives ofthe drug (whichever is shorter) before the first study drug administration.
Study Design
Connect with a study center
Rigshospitalet; Fase 1 Enhed - Onkologi
København Ø, 2100
DenmarkSite Not Available
Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Gustave Roussy
Villejuif CEDEX, 94800
FranceSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarra 31008
SpainSite Not Available
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
SpainSite Not Available
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Madrid, 28027
SpainSite Not Available
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, 28040
SpainSite Not Available
Western General Hospital; Edinburgh Cancer Center
Edinburgh, EH4 2XU
United KingdomSite Not Available
Guys and St Thomas Hospital; OHCT Clinical Trials
London, SE1 9RT
United KingdomSite Not Available
Christie Hospital NHS Trust; Experimental Cancer Medicine Team
Manchester, M20 4BX
United KingdomSite Not Available
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