Solid Tumour
Conditions
Brief summary
This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several key aspects of the study design and study population are summarized below.
Interventions
DRUGRO7759065
Specified dose on specified days
DRUGAtezolizumab
Specified dose on specified days
Sponsors
Genentech, Inc.
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 at least 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic and end-organ function * Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1 * Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy * Availability of representative tumor specimens required for patients in select cohorts.
Exclusion criteria
* Women who are pregnant or breastfeeding * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment * Active hepatitis B or C or tuberculosis * Positive test for human immunodeficiency virus (HIV) infection * Acute or chronic active Epstein-Barr virus (EBV) infection at screening * Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7759065 infusion * Primary, untreated, or active central nervous system (CNS) metastases * Active or history of autoimmune disease or immune deficiency * Prior allogeneic stem cell or organ transplantation * Any history of a Grade 3 immune-mediated adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of that agent * Any history of a Grade 4 immune-mediated adverse event attributed to prior cancer immunotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants iwth Dose Limiting Toxicity (DLTs) | Up to approximately 5 years |
| Number of Participants with Adverse Events (AEs) | Up to approximately 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DOR) | Up to approximately 5 years |
| Maximum Serum Concentration (Cmax) of RO7759065 | Up to approximately 5 years |
| Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7759065 | Up to approximately 5 years |
| Progression Free Survival (PFS) | Up to approximately 5 years |
| Objective Response Rate (ORR) | Up to Approximately 5 Years |
Countries
Australia, Canada, Spain, United States
Outcome results
None listed