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Evaluating YL201 in Patients with Advanced Solid Tumors

A Multicenter, Open-Label, Phase 1/2 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With Selected Advanced Solid Tumors

Phase1; Phase2 Interventional MediLink Therapeutics (Suzhou) Co., Ltd. · NCT06057922

This study is testing a new drug called YL201 to see if it is safe and effective for people with advanced solid tumors like lung and prostate cancer.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment990 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorMediLink Therapeutics (Suzhou) Co., Ltd. Industry-sponsored
Drugs / interventionsCAR-T, chimeric antigen receptor, Prednisone
Locations56 sites (Hefei, Anhui and 55 other locations)
Trial IDNCT06057922 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label study aims to assess the safety, efficacy, and pharmacokinetics of YL201 in patients with selected advanced solid tumors. The trial consists of two parts: a Phase 1 dose expansion stage to determine the recommended Phase 2 dose (RP2D) and a Phase 2 stage to further evaluate the drug's effectiveness and safety at the RP2D. Patients with various types of advanced solid tumors, including non-small cell lung cancer and metastatic prostate cancer, will be included in the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed advanced solid tumors and measurable lesions.

Not a fit: Patients with non-measurable lesions or those with a life expectancy of less than three months may not benefit from this study.

Why it matters

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

How similar studies have performed: Other studies involving antibody-drug conjugates have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.
* Age ≥18 years old and ≤75 years old
* Histologically or cytologically confirmed at diagnosis of NSCLC/SCLC/NPC/ESCC /mCRPC/HNSCC/Sarcoma/PDAC/HCC/BTC
* At least one extracranial measurable lesion according to RECIST 1.1.
* Archived or fresh tumor tissue samples can be provided.
* Eastern Cooperative Oncology Group - performance scale (ECOG PS) score of 0 or 1.
* Female subjects with fertility must agree to take high-efficiency contraceptive measures from screening to whole study period and within at least 6 months after last administration of investigational drug. Male subjects must agree to take high-efficiency contraceptive measures from screening to whole study period and within at least 6 months after last administration of investigational drug.
* Life expectancy ≥3 months.
* Capable or willing to observe the visits and procedures stipulated in study protocol.

Exclusion Criteria:

* Prior treatment with products targeting B7H3 (including antibodies, antibody-drug conjugate \[ADC\], chimeric antigen receptor T cells \[CAR-T\], and other drugs).
* Prior treatment with topoisomerase 1 inhibitors or ADC based on topoisomerase 1 inhibitors.
* Participation in another clinical trial meanwhile, except observatory (non-interventional) clinical trial or at follow-up period of interventional study.
* Washout period of previous anticancer treatment was insufficient before first administration of investigational drug.
* Major surgery (excluding diagnostic surgery) within 4 weeks before first administration of investigational drug or likely to require major surgery during the study.
* History of allogenic bone marrow transplantation or solid organ transplantation.
* Treatment with systemic steroid (Prednisone \>10 mg/d or equivalent drugs) or other immunosuppressive drugs within 2 weeks before first administration of investigational drug.
* Live vaccination within 4 weeks before first administration of investigational drug or likely to require live vaccine inoculation during the study.
* Evidence of leptomeningeal metastasis or carcinomatous meningitis.
* Evidence of brain metastasis or spinal cord compression.
* Evidence of cardiovascular disease with uncontrolled state or clinical significance.
* Clinically significant concomitant lung disease.
* Diagnosed as Gilbert syndrome.
* Complicated with uncontrolled third-space effusion .
* History of gastrointestinal perforation and/or fistula within 6 months before first administration.
* History of serious infection (Grade ≥3 of NCI CTCAE) before first administration.
* Known as infection with human immunodeficiency virus (HIV).
* Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
* History of any other primary malignant tumor within 5 years before first administration of investigational drug.
* The toxicity of previous anticancer treatment is not resolved.
* History of serious hypersensitive reactions to drug substance, inactive compositions of preparations or other monoclonal antibodies.
* Breastfeeding women. Or women confirmed as pregnant through pregnancy test within 3 days before first administration.
* Any disease, medical state, organ/system dysfunction or social state considered by investigators as possibly interfering the subject's capability for ICF signing, producing adverse influence on the subject's capability for cooperation and study participation or influencing the interpretation of study results. Including but not limited to mental disease or substance/alcohol abuse.

Where this trial is running

Hefei, Anhui and 55 other locations

+6 more sites — see ClinicalTrials.gov for the full list.

Study contacts

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 TumorAntibody-drug conjugate
Last reviewed 2026-06-13 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.