A Study YL201 in Patients With Selected Advanced Solid Tumors

NCT06057922 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: YL201-CN-101-01
• Study Type: interventional
• Target: 990
• Locations: 1 country
• Sites: 52

Brief 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.

Conditions

Advanced Solid Tumor

Keywords

Antibody-drug conjugate

Outcome Measures

Primary Outcomes (3)

• Evaluate the AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment

  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

  ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).

  Time Frame: Approximately within 36 months

• Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer

  PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline

  Time Frame: Approximately within 36 months

Secondary Outcomes (16)

• Characterize the PK parameter AUC

  Approximately within 36 months

• Characterize the PK parameter Cmax

  Approximately within 36 months

• Characterize the PK parameter Ctrough

  Approximately within 36 months

• Characterize the PK parameter CL

  Approximately within 36 months

• Characterize the PK parameter Vd

  Approximately within 36 months

Study Arms (2)

Phase 1 dose expansion stage

EXPERIMENTAL

Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle; and at dose levels of 1.0 mg/kg and 1.2 mg/kg administered on Days 1 and 8 of each Q3W treatment cycle.

Drug: YL201 for Injection

Phase 2 stage with expanded sample size

EXPERIMENTAL

Patients will be treated with YL201 intravenous (IV) infusion at PR2D once every 3 weeks (Q3W) as a cycle; and at dose levels of 1.0 mg/kg and 1.2 mg/kg administered on Days 1 and 8 of each Q3W treatment cycle.

Drug: YL201 for Injection

Interventions

YL201 for Injection DRUG

Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle; and at dose levels of 1.0 mg/kg and 1.2 mg/kg administered on Days 1 and 8 of each Q3W treatment cycle.

Phase 1 dose expansion stage; Phase 2 stage with expanded sample size

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (52)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

The First Affiliated Hospital of USTC

Hefei, Anhui, China

Location

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Location

Dongguan People's Hospital

Dongguan, Guangdong, China

Location

The Frist People's Hospital of Foshan

Foshan, Guangdong, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Location

Yuebei People's Hospital

Shaoguan, Guangdong, China

Location

The Fifth Affiliated Hospital Sun Yat-Sen University

Zhuhai, Guangdong, China

Location

The Second Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Location

Liuzhou People's Hospital

Liuchow, Guangxi, China

Location

Liuzhou Worker's Hospital

Liuchow, Guangxi, China

Location

Affiliated Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Location

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Location

Affiliated Hospital of Chengde Medical University

Chengde, Hebei, China

Location

Harbin Medical University Cancer Hospital

Haerbin, Heilongjiang, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Location

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Location

Nantong Tumor Hospital

Nantong, Jiangsu, China

Location

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Location

Jiangyin People's Hospital

Wuxi, Jiangsu, China

Location

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Location

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

Location

Jiangxi Cancer Hospital (Jiangxi Second People's Hospital)

Nanchang, Jiangxi, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

Location

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Location

Shandong Provincial Hospital

Jinan, Shandong, China

Location

Linyi Cancer Hospital

Linyi, Shandong, China

Location

Shanxi Cancer Hospital

Datong, Shanxi, China

Location

The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University

Xian, Shanxi, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Location

West China Hospital of Sichuan University

Huaxi, Sichuan, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Location

Related Publications (1)

• Ma Y, Yang Y, Huang Y, Fang W, Xue J, Meng X, Fan Y, Fu S, Wu L, Zheng Y, Liu J, Liu Z, Zhuang W, Rosen S, Qu S, Li B, Li M, Zhao Y, Yang S, Ji Y, Sommerhalder D, Luo S, Yang K, Li J, Lv D, Zhang P, Zhao Y, Hong S, Zhang Y, Zhao S, Chin S, Zhang X, Lian W, Cai J, Xue T, Zhang L, Zhao H. A B7H3-targeting antibody-drug conjugate in advanced solid tumors: a phase 1/1b trial. Nat Med. 2025 Jun;31(6):1949-1957. doi: 10.1038/s41591-025-03600-2. Epub 2025 Mar 13.

  PMID: 40082695 DERIVED

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: September 22, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

CN (52)