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NCT Number: NCT07407933

A Study 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Site 1201, Namur, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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 failure)

Other protocol-defined inclusion/ exclusion criteria may apply.

Treatment and study plan

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

Primary outcomes

  1. Nature and Frequency with Dose-Limiting Toxicities (DLTs)

    Time frame: 21 days

  2. 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

Secondary outcomes

  1. ORR

    Time frame: Up to approximately 3 years

  2. DOR

    Time frame: Up to approximately 3 years

  3. PFS

    Time frame: Up to approximately 3 years

  4. OS

    Time frame: Up to approximately 3 years

  5. AUC

    Time frame: Up to approximately 3 years

  6. CL

    Time frame: Up to approximately 3 years

  7. Vss

    Time frame: Up to approximately 3 years

  8. t1/2

    Time frame: Up to approximately 3 years

  9. Cmax

    Time frame: Up to approximately 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

MediLink Study Team

CONTACT

[email protected]

86 0512-62858368

Sponsors and collaborators

Lead sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Industry

Collaborators

  • Genentech, Inc.
  • Hoffmann-La Roche

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 12, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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