Locally Advanced or Metastatic Solid Tumors A solid tumor/cancer is an abnormal tissue mass that arises from uncontrolled growth of cells and continues to grow locally or spread to other parts of the body (metastatic).
Conditions
Interventions
The investigational medicinal products for this study are RO7502175 (Phase Ia
and Ib) and atezolizumab (Phase Ib only). RO7502175 will be administered on
Day 1 of every 21-day cycle by IV infusion i
Sponsors
Genentech Inc. c/o F. Hoffmann-La Roche Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Life expectancy >= 12 weeks - Adequate hematologic and end-organ function - Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy - Availability of representative tumor specimens - Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases - History of leptomeningeal disease - Significant cardiovascular disease within 3 months prior to initiation of study treatment - History of malignancy other than disease under study within 3 years prior to screening - Any immune-mediated adverse events related to prior cancer immunotherapy that have not resolved completely to baseline - Active or history of autoimmune disease or immune deficiency - Active tuberculosis, hepatitis B or acute or chronic active EBV infection - Positive test for human immunodeficiency virus (HIV) infection - Positive hepatitis C virus (HCV) antibody test - Known infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) - Major surgical procedure or significant traumatic injury within 28 days prior to first study drug infusion - Prior allogeneic stem cell or organ transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety objective: The safety objective for this study is to evaluate the safety of RO7502175 when administered as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib), including characterization of dose-limiting toxicities (DLTs), on the basis of the following endpoints: • Incidence and nature of DLTs • Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 • Change from baseline in targeted vital signs • Change from baseline in targeted clinical laboratory test results • Change from baseline in ECG parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic objectives: The pharmacokinetic (PK) objective for this study is to characterize the RO7502175 PK profile when administered as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) on the basis of the following endpoint: • Serum concentration of RO7502175 at specified timepoints Activity objectives: The activity objective for this study is to make a preliminary assessment of the activity of RO7502175 when administered as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) on the basis of the following endpoints: • Objective response rate (ORR), defined as the proportion of patients with a complete response or partial response on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1 • Duration of response (DOR), defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1 • Progression-free survival (PFS) after enrollment, defined as the time from enrollment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1 Immunogenicity objectives: The immunogenicity objective for this study is to evaluate the immune response to RO7502175 when administered as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) on the basis of the following endpoints: • Prevalence of anti-drug antibodies (ADAs) to RO7502175 at baseline (baseline prevalence) and incidence of ADAs to RO7502175 after initiation of study treatment (post-baseline incidence) Biomarker objective: The exploratory biomarker objective for this study is to identify and/or evaluate biomarkers that are predictive of response to RO7502175 when administered as a single agent (Phase Ia) or in combination with atezolizumab | — |
Countries
Netherlands
Outcome results
None listed