A Study of YL201 in Combination with Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medilink Therapeutics (Suzhou) Co. Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

28 Apr 2026 → ongoing

Decision date (initial)

2026-03-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Safety

Part 1
Primary Objectives
• To assess the safety of YL201 in combination with atezolizumab
• To determine the maximum tolerated dose (MTD) for YL201 in combination with atezolizumab
Part 2
Primary Objectives
• To assess the anti-tumor activity of YL201 in combination with atezolizumab

Secondary objectives 1

1. Part 1 Secondary Objectives • To characterize the PK of YL201 in combination with atezolizumab • To evaluate the immunogenicity and the anti-tumor activity of YL201 in combination with atezolizumab Part 2 Secondary Objectives • To evaluate the safety and tolerability, immunogenicity, antitumor activity of YL201 in combination with atezolizumab • To characterize the PK of YL201 To identify a recommended dose of YL201 in combination with atezolizumab

Conditions and MedDRA coding

Advanced solid tumors

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Capable of providing written informed consent.
2. 18 years of age or older
3. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
4. Pathologically confirmed diagnosis of ES-SCLC
5. No prior systemic anti-cancer treatment
6. Have at least 1 evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
7. Adequate organ and bone marrow function
8. Life expectancy of ≥3 months

Exclusion criteria 12

1. Any prior targeting B7H3 treatments
2. Any prior therapy with TOP1 inhibitors or ADCs composed of TOP1 inhibitors
3. Undergone major surgery within 4 weeks before the first dose of study drug or expect major surgery during the study
4. Symptomatic or actively progressing brain metastases
5. Active or prior documented autoimmune, inflammatory disorders, or immune deficiency, autoimmune pneumonitis, and autoimmune myocarditis
6. Received any live vaccine within 4 weeks before the first dose of study drug
7. Received systemic steroids or other immunosuppressive therapy within 2 weeks prior to initiation of study treatment
8. Clinically significant concomitant pulmonary disease
9. Uncontrolled or clinically significant cardiovascular disease
10. Uncontrolled infection that requires systemic therapy
11. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
12. A history of severe hypersensitivity reactions to drug substances, inactive ingredients in the drug product, or other mAbs

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Part 1 Primary Endpoints • AEs, laboratory abnormalities and DLTs
2. Part 2 Primary Endpoints • ORR: assessed using RECIST version 1.1 • PFS: assessed using RECIST version 1.1

Secondary endpoints 2

1. Part 1: Secondary Endpoints • PK parameters • Incidence of anti-YL201 antibodies • ORR: assessed using RECIST version 1.1
2. Part 2: • AEs and laboratory abnormalities • PK parameters • Incidence of anti-YL201 antibodies • DOR: assessed using RECIST version 1.1 • OS

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medilink Therapeutics (Suzhou) Co. Ltd.

Sponsor organisation

Medilink Therapeutics (Suzhou) Co. Ltd.

Address

B3-101 Biobay 218 Xinghu Street, Suzhou Industrial Park, Jiangsu Pilot Free Trade Zone Suzhou Industrial Park Jiangsu Pilot Free Trade Zone

City

Suzhou

Postcode

215123

Country

China

Scientific contact point

Organisation

Medilink Therapeutics (Suzhou) Co. Ltd.

Contact name

Medilink Therapeutics

Public contact point

Organisation

Medilink Therapeutics (Suzhou) Co. Ltd.

Contact name

Medilink Therapeutics

Locations

8 EU/EEA countries · 32 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 100 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications