NCT06057922

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

Active, enrolled Phase 1/Phase 2 Last updated 11 March 2026

What this trial tests

Phase 1/Phase 2 trial testing YL201 for Injection in Advanced Solid Tumor in 990 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 September 2023

Primary endpoint
1 October 2026

1 October 2028

Quick facts

Lead sponsor	MediLink Therapeutics (Suzhou) Co., Ltd.
Phase	Phase 1/Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	990
Start date	22 September 2023
Primary completion	1 October 2026
Estimated completion	1 October 2028
Sites	52 locations across China

Drugs / interventions tested

• YL201 for Injection — full drug profile →

Conditions studied

• Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

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

Who can join

Adults 18 to 75, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Evaluate the AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment
  Time frame: By the global end of trial date, approximately within 36 months
• Evaluate the objective response rate (ORR) for patients with solid tumors which assessed using RECIST version 1.1
  Time frame: Time Frame: Approximately within 36 months
  ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).
• Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer
  Time frame: Time Frame: Approximately within 36 months
  PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline

Sponsor's own description

This is A Multicenter, Open-Label, Phase 1/2 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients with Selected Advanced Solid Tumors. The study will include 2 parts: Phase 1 dose expansion stage (Part 1) followed by a Phase 2 stage with expanded sample size (Part 2).

Part 1 will estimate the RP2D in dose expansion cohorts of patients with not linited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), nasopharyngeal carcinoma (NPC), esophageal squamous cell carcinoma (ESCC), metastatic castration-resistant prostate cancer (mCRPC), head and neck squamous cell carcinoma (HNSCC), sarcoma, ductal adenocarcinoma of pancreas (PDAC), hepatocellular carcinoma (HCC), biliary tract cancer (BTC), etc..

Part 2 will include patients with selected advanced solid tumor types enrolled at the RP2D to further assess the efficacy and safety 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 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
4. 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
5. 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
6. Prevalence of antibody drug conjugated-induced nausea and vomiting (ADCINV) in patients with cancer.
   Chow R, Zhang D, Kannout S, Ma A, et al · · 2026 · PMID 42068413 · DOI 10.1007/s00520-026-10674-2
7. Targeted Therapy in Hepatobiliary Pancreatic Cancer (HPC): Advantages and Advancements of Antibody Drug Conjugates, a Type of Chemo-Biologic Hybrid Drugs.
   Deb Nath T, Mukherjee A, Chauhan SC, Bandyopadhyay D. · · 2026 · PMID 41898574 · DOI 10.3390/ijms27062707
8. Does the B7-H3 Immune Checkpoint Have High Potential as a Therapeutic Target?
   Agostini M, Traldi P, Hamdan M. · · 2026 · PMID 41677606 · DOI 10.3390/cells15030239