Locally advanced or metastatic solid tumors Cancer
Conditions
Interventions
This clinical trial includes three groups (Stages) as follows
• Phase Ia Dose Escalation Stage: STA551 as single agent
• Phase Ib Dose Escalation Stage: STA551 + Atezolizumab
• Phase Ib Expansion Stages: STA551 + Atezolizumab
STA551, atezolizumab are given dif
Sponsors
Chugai Pharmaceutical Co., Ltd. (Japan)
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent Form (ICF) 2. Age =18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Adequate hematologic and end organ function 5.Histologically or cytologically documented solid tumors 6. Dose escalation cohorts: standard of care has proven to be ineffective or intolerable or is considered inappropriate. Patients with evaluable disease per RECIST v1.1 7. Expansion cohorts: Patients with a measurable disease as per RECIST v1.1
Exclusion criteria
Exclusion criteria: 1. Clinically significant New York Heart Association cardiac disease (Class II or greater), myocardial infaction within the previous 3 months, unstable arrhythmias, and/or unstable angina 2. Prior treatment with anti-CD137 agents 3. History or complication of autoimmune disease 4. Any history or grade 3 immune-related adverse event (irAE) that resulted in permanent discontinuation of prior immunotherapeutic agent, or Grade 2 irAE attributed prior anti-PD-L1/PD-1 or anti CTLA-4 therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) of STA551 when administered as a single agent (Phase Ia) and in combination with atezolizumab (Phase Ib) in patients with locally advanced or metastatic solid tumors measured using Incidence of dose-limiting toxicities (DLTs) at During the DLT evaluation period;Safety and tolerability of STA551 when administered as a single agent and in combination with atezolizumab measured using Incidence, nature, and severity of adverse events graded according to NCI CTCAE v5.0 at Throughout the study;Pharmacokinetics of STA551 administered as a single agent and in combination with atezolizumab measured using Serum concentration of STA551 and derived PK parameters (AUC, Cmax, Cmin, CL, Vd, accumulation ratio, t1/2, dose proportionality) at During treatment cycles (depending on the schedule of each cohort);Preliminary anti-tumor activity of STA551, when administered in combination with atezolizumab measured using Objective response (OR), defined as a confirmed CR, partial response (PR) or stable disease (SD) per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as determined by the investigator at The end of Cycle 2, 4, 6, and 8, and then every 4 cycles thereafter (one cycle consists of 21 days), or as clinically indicated;Exploratory pharmacodynamic response when STA551 is administered at the selected dose as a single agent followed by combination with atezolizumab measured using Increase of Zr-89 crefmirlimab berdoxam (CD8 PET tracer) uptake as measured by change from baseline in background corrected Standardized Uptake Value (SUV)-based quantitative measures (e.g. SUVmax, SUVpeak, SUVmean) at Cycle 0 Day 2, Cycle 2 Day 9, and Cycle 4 Day 9 | — |
Countries
England, Japan, Poland, Romania, Spain, Taiwan, United Kingdom
Contacts
Public ContactUdai Banerji
Outcome results
None listed