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A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Other Anti-Cancer Therapies in Patients with Advanced Solid Tumors

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523742-27-00
Enrollment
35
Registered
2026-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-18

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

Conditions

Advanced solid tumors

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.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Source: EU CTIS · Data processed: Mar 19, 2026