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Evaluating YL201 for Advanced Solid Tumors

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Serplulimab with or Without Platinum-based Chemotherapy in Selected Subjects with Advanced Solid Tumors

Phase 1 Interventional MediLink Therapeutics (Suzhou) Co., Ltd. · NCT06394414

This study is testing a new treatment called YL201, combined with another drug, to see if it helps people with advanced solid tumors feel better and improve their health.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment162 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorMediLink Therapeutics (Suzhou) Co., Ltd. Industry-sponsored
Drugs / interventionsSerplulimab, Chemotherapy
Locations30 sites (Beijing, Beijing Municipality and 29 other locations)
Trial IDNCT06394414 on ClinicalTrials.gov

What this trial studies

This phase 1 clinical trial aims to assess the safety, efficacy, and pharmacokinetics of YL201 in combination with serplulimab, with or without platinum-based chemotherapy, in patients with advanced solid tumors. The study is divided into two parts: the first part focuses on dose escalation to determine the maximum tolerated dose and safety profile, while the second part evaluates the efficacy of the treatment. Conducted in multiple centers across China, the trial will include patients with various types of advanced solid tumors.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced solid tumors such as nasopharyngeal carcinoma (NPC), small cell lung cancer (SCLC), and non-small cell lung cancer (NSCLC) who meet specific eligibility criteria.

Not a fit: Patients with early-stage tumors or those who do not have measurable lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: While this approach is being explored in this specific combination, similar studies have shown promise in treating advanced solid tumors with targeted therapies and immunotherapies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 1\) Informed of the study before the start of the study and voluntarily sign their name and date on the informed consent form (ICF).

  2\) Subjects will be enrolled in the dose-escalation phase: Advanced solid tumors, like NPC, SCLC and etc.

  3\) Subjects will be enrolled in the dose-expansion phase: NPC, SCLC, NSCLC and other advanced cancer.

  4\) According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, there must be at least one extracranial measurable lesion.

  5\) Archived or fresh tumor tissue samples can be provided. 6) Within 7 days before the first dose, organ and bone marrow functions must meet the requirements.

  7\) Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 by the United States of America standards.

  8\) Female subjects of childbearing potential must agree to use highly effective contraception measures from screening throughout the duration of the study and for at least 6 months after the last dose of the study drug. Male subjects must agree to use highly effective contraception measures from screening throughout the duration of the study and for at least 6 months after the last dose of the study drug.

  9\) Subjects with expected survival ≥ 3 months. 10) Capable and willing to comply with the study protocol's scheduled visits and procedures.

Exclusion Criteria:

* 1\) Suitable for local radical treatment. 2) Previous Drug therapy targeting B7H3. 3) Previous Drug therapy with topoisomerase I inhibitors or ADCs composed of topoisomerase I inhibitors.

  4\) Prior treatment with anti-PD-(L)1, other immune checkpoint inhibitors, immune checkpoint agonists, or immunocellular therapies and other therapies targeting tumor immunity mechanisms.

  5\) Toxicity from previous anticancer treatments has not resolved. 6) Concurrent enrollment in another clinical study. 7) Inadequate washout period for prior anticancer treatment before the first dose of study drug.

  8\) Underwent major surgery (excluding diagnostic surgery) or suffered serious trauma.

  9\) Received allogeneic stem cell or solid organ transplant. 10) Active autoimmune diseases requiring systemic treatment. 11) Received systemic steroids. 12) Metastases to meninges or carcinomatous meningitis. 13) Brain metastasis or spinal cord compression. 14) Uncontrolled or clinically significant cardiovascular disease. 15) Clinically significant concomitant pulmonary disease. 16) With uncontrolled third-space fluid. 17) History of gastrointestinal perforation and / or fistula within 6 months prior to the first dose.

  18\) Serious Infection prior to the first dose. 19) Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

  20\) Any other primary malignancy before the first dose of study drug. 21) A history of severe hypersensitivity reactions to the investigational product, inactive ingredients in the formulation, or other monoclonal antibodies.

  22\) Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 3 days before the first dose.

  23\) Any illness, medical condition, organ system dysfunction, or social situation.

Where this trial is running

Beijing, Beijing Municipality and 29 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid Tumors
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.