Last reviewed · How we verify

NCT05434234

A Study of YL201 in Patients With Advanced Solid Tumors

Recruiting now Phase 1, PHASE2 Last updated 10 November 2025
What this trial tests

Phase 1, PHASE2 trial testing YL201 in Advanced Solid Tumor in 312 participants. Currently enrolling.

Timeline
25 May 2022
Primary endpoint
6 April 2027
6 October 2027

Quick facts

Lead sponsorMediLink Therapeutics (Suzhou) Co., Ltd.
PhasePhase 1, PHASE2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment312
Start date25 May 2022
Primary completion6 April 2027
Estimated completion6 October 2027
Sites45 locations across France, Poland, Canada, China, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201 conducted in China and the United States. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2). Part 1 will estimate the MTD/RED(s) in dose escalation cohorts of patients with advanced solid tumors unresponsive to currently available therapies or for whom no standard therapy is available. Part 2 will include patients with selected advanced solid tumor types enrolled at the MTD/RED(s), to better define the safety profile and evaluate the efficacy of YL201.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A B7H3-targeting antibody-drug conjugate in advanced solid tumors: a phase 1/1b trial.
    Ma Y, Yang Y, Huang Y, Fang W, et al · · 2025 · cited 46× · PMID 40082695 · DOI 10.1038/s41591-025-03600-2
  2. Resistance to antibody-drug conjugates: A review.
    Li S, Zhao X, Fu K, Zhu S, et al · · 2025 · cited 32× · PMID 40177568 · DOI 10.1016/j.apsb.2024.12.036
  3. Antibody drug conjugates in the clinic.
    Udofa E, Sankholkar D, Mitragotri S, Zhao Z. · · 2024 · cited 12× · PMID 39545074 · DOI 10.1002/btm2.10677
  4. Immunotherapy in lung cancer brain metastases.
    Paisana E, Cascão R, Alvoeiro M, Félix F, et al · · 2025 · cited 8× · PMID 40328894 · DOI 10.1038/s41698-025-00901-0
  5. Antibody-drug conjugates in cancer therapy: current landscape, challenges, and future directions.
    Chen B, Zheng X, Wu J, Chen G, et al · · 2025 · cited 4× · PMID 41184856 · DOI 10.1186/s12943-025-02489-2
  6. The evolving landscape of antibody-drug conjugates (ADCs) for treatment of prostate cancer.
    Lin C, Hadfield MJ, Santopietro A, Lagos G, et al · · 2025 · cited 1× · PMID 41238753 · DOI 10.1038/s41698-025-01131-0
  7. Antibody-drug conjugates in recurrent or metastatic HNSCC: relevant targets, clinical development, and future prospects.
    Zhao H, Zhang S, Wang F, Yu P, et al · · 2026 · PMID 42254025 · DOI 10.3389/fimmu.2026.1828131
  8. Emerging Immunotherapy and Antibody-Derived Therapeutics for the Treatment of Advanced Non-Small-Cell Lung Cancer: A Review.
    Hou AY, Elantably D, Manochakian R, Velcheti V, et al · · 2026 · PMID 42073614 · DOI 10.3390/cancers18081291

Verify or expand the search:

Other trials of YL201

Trials testing the same drug.

Other recruiting trials for Advanced Solid Tumor

Currently open trials in the same condition.

Other MediLink Therapeutics (Suzhou) Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05434234.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing