A PHASE Ia/Ib STUDY OF STA551 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH SOLID TUMORS

A PHASE Ia/Ib OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF STA551 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225058

Enrollment

233

Registered

2020-02-12

Start date

2020-03-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

Interventions

investigational material(s) Generic name etc : STA551 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age >= 18 years (Age >= 20 years in Japan) - ECOG Performance Status of 0 or 1 - Adequate hematologic and end organ function - Histologically or cytologically documented solid tumors (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. (Expansion Cohorts) - STA551 in combination with an anti-PD-L1 antibody is considered an acceptable treatment option. - Patients with measurable disease per RECIST v1.1.

Exclusion criteria

Exclusion criteria: - clinically significant New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, and/or unstable angina. - Prior treatment with anti-CD137 agents - History or complication of autoimmune disease - Any history of a Grade 3 immune-related adverse event (irAE) that resulted in permanent discontinuation of the prior immunotherapeutic agent, or Grade 4 irAE attributed to prior anti-PD-L1/PD-1 or anti-CTLA-4 therapy

Design outcomes

Primary

Measure	Time frame
safety efficacy exploratory pharmacokinetics (Dose Escalation Cohort) tolerability and safety for STA551 single agentor in combination with atezolizumab, pharmacokinetics for STA551 (Expansion Cohort) preliminary efficacy for STA551 in combination with atezolizumab, safety for STA551 in combination with atezolizumab, pharmacokinetics for STA551 Method: Observation/test	—

Secondary

Measure	Time frame
efficacy exploratory pharmacokinetics other other(immunegenicity) preliminary efficacy for STA551 single agent or in combination with atezolizumab(Dose Escalation Cohort), pharmacokinetics for atezoizumab, anti-drug antibody Method: Observation/test exploratory pharmacodynamics biomarker Method: Observation/test	—

Countries

Japan, Poland, Romania, Taiwan, United Kingdom

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026