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

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

This is a phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. The planned dose levels of YL201 are 1.2 mg/kg, 1.6 mg/kg and 2.0 mg/kg. Part 2 consists of a dose optimization stage followed by a dose expansion stage. During the dose optimization stage, participants will be randomized 1:1:1 to receive either YL201 at 1.2 mg/kg,1.6 mg/kg or 2.0 mg/kg Q3W in combination with fixed dose of atezolizumab. The decision to initiate the dose expansion stage in Part 2 and choose one or two of the YL201 dose level(s) will be based on the review of safety, PK, and efficacy from the dose optimization stage. Treatment will continue until disease progression, unacceptable toxicity, or withdraw of consent.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma
• Intervention / Treatment: Drug: YL201; Drug: Atezolizumab

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: MediLink Study Team; Phone Number: 86 0512-62858368; Email: clinicaltrials@medilinkthera.com

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0HS
    • Recruiting
    • Site 2201
    • Contact: Study Coordinator
• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20057
      • Not yet recruiting
      • Site 1001
      • Contact: Study Coordinator
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Site 1005
      • Contact: Study Coordinator
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Site 1002
      • Contact: Study Coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1.18 years of age or older. 2. Histologically or cytologically confirmed diagnosis of ES-SCLC 3. Eastern Cooperative Oncology Group performance status of 0 or 1 4. Adequate hematologic and end-organ function

Exclusion Criteria:

1. No prior systemic anti-cancer treatment for ES-SCLC
2. No prior treatment targeting B7H3 or topoisomerase I inhibitor
3. No clinically active brain metastases or spinal cord compression
4. No current or history of interstitial lung disease (ILD)/ pneumonitis
5. No clinically significant cardiovascular disease (eg, New York Heart Association class II to IV congestive heart failure)

Other protocol-defined inclusion/ exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W	Drug: YL201; YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.; Drug: Atezolizumab; Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle
Experimental: YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W	Drug: YL201; YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.; Drug: Atezolizumab; Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle
Experimental: YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W	Drug: YL201; YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.; Drug: Atezolizumab; Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nature and Frequency with Dose-Limiting Toxicities (DLTs)		21 days
Adverse Events	Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5	First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years)

Secondary Outcome Measures

Outcome Measure	Time Frame
OS	Up to approximately 3 years
ORR	Up to approximately 3 years
DOR	Up to approximately 3 years
PFS	Up to approximately 3 years
AUC	Up to approximately 3 years
CL	Up to approximately 3 years
Vss	Up to approximately 3 years
t1/2	Up to approximately 3 years
Cmax	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
• Collaborators: Hoffmann-La Roche; Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Small cell lung cancer, Antibody drug conjugate, YL201, atezolizumab
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Small Cell Lung Carcinoma; Thoracic Neoplasms; atezolizumab
• Other Study ID Numbers: YL201-INT-102-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No