Advanced solid tumors
Conditions
Brief summary
Part 1 Primary Endpoints • AEs, laboratory abnormalities and DLTs, Part 2 Primary Endpoints • ORR: assessed using RECIST version 1.1 • PFS: assessed using RECIST version 1.1
Detailed description
Part 1: Secondary Endpoints • PK parameters • Incidence of anti-YL201 antibodies • ORR: assessed using RECIST version 1.1, Part 2: • AEs and laboratory abnormalities • PK parameters • Incidence of anti-YL201 antibodies • DOR: assessed using RECIST version 1.1 • OS
Interventions
DRUGTecentriq 1 200 mg concentrate for solution for infusion
DRUGYL201
Sponsors
Medilink Therapeutics (Suzhou) Co. Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 Primary Endpoints • AEs, laboratory abnormalities and DLTs, Part 2 Primary Endpoints • ORR: assessed using RECIST version 1.1 • PFS: assessed using RECIST version 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Secondary Endpoints • PK parameters • Incidence of anti-YL201 antibodies • ORR: assessed using RECIST version 1.1, Part 2: • AEs and laboratory abnormalities • PK parameters • Incidence of anti-YL201 antibodies • DOR: assessed using RECIST version 1.1 • OS | — |
Outcome results
None listed