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

June 11, 2026 updated by: MediLink Therapeutics (Suzhou) Co., Ltd.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Namur, Belgium, 5000
        • Recruiting
        • Site 1201
        • Contact:
          • Study Coordinator
  • Italy
      • Meldola, Italy, 47014
        • Recruiting
        • Site 1703
        • Contact:
          • Study Coordinator
      • Ravenna, Italy, 48121
        • Recruiting
        • Site 1702
        • Contact:
          • Study Coordinator
  • Poland
      • Otwock, Poland, 05-400
        • Recruiting
        • Site 1802
        • Contact:
          • Study Coordinator
      • Poznan, Poland, 60-569
        • Recruiting
        • Site 1804
        • Contact:
          • Study Coordinator
      • Przemyśl, Poland, 37-700
        • Recruiting
        • Site 1801
        • Contact:
          • Study Coordinator
  • Romania
      • Craiova, Romania, 109
        • Recruiting
        • Site 1901
        • Contact:
          • Study Coordinator
  • Spain
      • Badajoz, Spain, 06080
        • Recruiting
        • Site 2013
        • Contact:
          • Study Coordinator
      • Barcelona, Spain, 08017
        • Recruiting
        • Site 2014
        • Contact:
          • Study Coordinator
      • Barcelona, Spain, 08023
        • Recruiting
        • Site 2003
        • Contact:
          • Study Coordinator
      • Madrid, Spain, 28034
        • Recruiting
        • Site 2002
        • Contact:
          • Study Coordinator
      • Madrid, Spain, 28040
        • Recruiting
        • Site 2005
        • Contact:
          • Study Coordinator
      • Madrid, Spain, 28223
        • Recruiting
        • Site 2004
        • Contact:
          • Study Coordinator
      • Madrid, Spain, 28850
        • Recruiting
        • Site 2011
        • Contact:
          • Study Coordinator
      • Manresa, Spain, 08242
        • Recruiting
        • Site 2010
        • Contact:
          • Study Coordinator
      • Valencia, Spain, 46010
        • Recruiting
        • Site 2009
        • Contact:
          • Study Coordinator
      • Valencia, Spain, 46026
        • Recruiting
        • Site 2015
        • Contact:
          • Study Coordinator
  • 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
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Site 1004
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 21 days
21 days
Adverse Events
Time Frame: First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years)
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
Time Frame: Up to approximately 3 years
Up to approximately 3 years
ORR
Time Frame: Up to approximately 3 years
Up to approximately 3 years
DOR
Time Frame: Up to approximately 3 years
Up to approximately 3 years
PFS
Time Frame: Up to approximately 3 years
Up to approximately 3 years
AUC
Time Frame: Up to approximately 3 years
Up to approximately 3 years
CL
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Vss
Time Frame: Up to approximately 3 years
Up to approximately 3 years
t1/2
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Cmax
Time Frame: Up to approximately 3 years
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Collaborators

Hoffmann-La Roche
Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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