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A Study YL201 in Patients With Selected Advanced Solid Tumors | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

A Study YL201 in Patients With Selected 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

NCT06057922•MediLink Therapeutics (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+13 more criteria

Locations (52)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

The First Affiliated Hospital of USTC

Hefei, Anhui, China

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Dongguan People's Hospital

Dongguan, Guangdong, China

The Frist People's Hospital of Foshan

Foshan, Guangdong, China

Key Dates

Start Date

September 22, 2023

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2028

Last Updated

March 12, 2026

Enrollment

990

ESTIMATED participants

Conditions

Advanced Solid Tumor

Interventions

YL201 for Injection

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study YL201 in Patients With Selected Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

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