Solid Tumors
Conditions
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-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.
Interventions
DRUGRO7300490
Participants will receive RO7300490, as described in the Arm Descriptions.
DRUGAtezolizumab
Participants will receive Atezolizumab, as described in the Arm Descriptions.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events (AEs) (Parts 1 and 2) | Up to 36 months |
| Percentage of Participants with Dose-Limiting Toxicities (DLTs) (Parts 1 and 2) | Up to 36 months |
| Objective Response Rate (ORR) (Part 3) | Up to 48 months |
Secondary
| Measure | Time frame |
|---|---|
| Clearance (CL) of RO7300490 (Parts 1, 2 and 3) | Up to 48 months |
| Volume of Distribution at Steady State (Vss) of RO7300490 (Parts 1, 2 and 3) | Up to 48 months |
| Percentage of Participants with Anti-RO7300490 Antibodies (Parts 1, 2 and 3) | Up to 48 months |
| Objective Response Rate (ORR) (Parts 1 and 2) | Up to 48 months |
| Area Under The Curve (AUC) of RO7300490 (Parts 1, 2 and 3) | Up to 48 months |
| Duration of Response (DOR) (Parts 1, 2 and 3) | Up to 48 months |
| Progression-Free Survival (PFS) On-Treatment (Parts 1, 2 and 3) | Up to 48 months |
| Percentage of Participants With Adverse Events (AEs) (Part 3) | Up to 48 months |
| Disease Control Rate (DCR) (Parts 1, 2 and 3) | Up to 48 months |
| Minimum Concentration (Cmin) of RO7300490 (Parts 1, 2 and 3) | Up to 48 months |
| Maximum Concentration (Cmax) of RO7300490 (Parts 1, 2 and 3) | Up to 48 months |
Countries
Denmark, France, South Korea, Spain, United Kingdom
Outcome results
None listed