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Looking for participantsPhase1/Phase2

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

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

NCT ID: NCT07407933

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
YL201 (drug), Atezolizumab (drug)
How long the study runs
Study runs about 35 months (dates as stated)
About the drug or intervention
YL201 — drug: YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle. · Atezolizumab — drug: Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
118
Started
2026-03-31
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for thoracic neoplasms, lung diseases, small cell lung carcinoma
  • • Phase1/Phase2 - 118 participants
  • • This is a phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with thoracic neoplasms, lung diseases, small cell lung carcinoma

Where?

  • • Edinburgh - Site 2203
  • • London - Site 2201

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must NOT have had:

  • ✗ systemic anti-cancer
  • ✗ treatment targeting B7H3 or topoisomerase I inhibitor

Who cannot take part

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

Where Is This Study? (2 UK sites)

Site 2203

Edinburgh EH4 2XU, United Kingdom

Recruiting

Site 2201

London W12 0HS, United Kingdom

Recruiting

How to Get in Touch

MediLink Study Team

Sponsor contact

CONTACT

86 0512-62858368 clinicaltrials@medilinkthera.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09