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Advanced Solid TumorPhase 1/2NCT06057922

A Study YL201 in Patients With Selected Advanced Solid Tumors

A Phase 1/2 study testing YL201 for Injection in people with Advanced Solid Tumor, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 52 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
YL201 for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
990 participants
Where
52 sitesChina
Study dates
22 Sep 2023to Oct 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

China52 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality

  • The First Hospital of Jilin University

    Changchun, Jilin

  • Hunan Cancer Hospital

    Changsha, Hunan

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

  • Shanxi Cancer Hospital

    Datong, Shanxi

  • Dongguan People's Hospital

    Dongguan, Guangdong

  • The Frist People's Hospital of Foshan

    Foshan, Guangdong

  • Fujian Cancer Hospital

    Fuzhou, Fujian

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong

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

    Guangzhou, Guangdong

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi

  • Harbin Medical University Cancer Hospital

    Haerbin, Heilongjiang

  • The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • The First Affiliated Hospital of USTC

    Hefei, Anhui

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

  • West China Hospital of Sichuan University

    Huaxi, Sichuan

  • Jiangmen Central Hospital

    Jiangmen, Guangdong

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong

  • Shandong Provincial Hospital

    Jinan, Shandong

  • Linyi Cancer Hospital

    Linyi, Shandong

  • Liuzhou People's Hospital

    Liuzhou, Guangxi

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • Jiangxi Cancer Hospital (Jiangxi Second People's Hospital)

    Nanchang, Jiangxi

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi

  • Nantong Tumor Hospital

    Nantong, Jiangsu

  • Yuebei People's Hospital

    Shaoguan, Guangdong

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu

  • Jiangyin People's Hospital

    Wuxi, Jiangsu

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

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

    Xian, Shanxi

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • The Fifth Affiliated Hospital Sun Yat-Sen University

    Zhuhai, Guangdong

Other trials in China

About this study

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

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.

Being tested
YL201 for Injection
Keywords
Antibody-drug conjugate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YL201 for InjectionDrug

    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.

Study groups in NCT06057922
Study groupRoleWhat they receive
Phase 1 dose expansion stageExperimentalPatients 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.
Receives: Drug: YL201 for Injection
Phase 2 stage with expanded sample sizeExperimentalPatients 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.
Receives: Drug: YL201 for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: By the global end of trial date, approximately within 36 months

  2. 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).

    Measured: Time Frame: Approximately within 36 months

  3. 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

    Measured: Time Frame: Approximately within 36 months

Secondary outcomes (16)

  1. Characterize the PK parameter AUC

    Measured: Approximately within 36 months

  2. Characterize the PK parameter Cmax

    Measured: Approximately within 36 months

  3. Characterize the PK parameter Ctrough

    Measured: Approximately within 36 months

  4. Characterize the PK parameter CL

    Measured: Approximately within 36 months

  5. Characterize the PK parameter Vd

    Measured: Approximately within 36 months

  6. Characterize the PK parameter t1/2

    Measured: Approximately within 36 months

  7. Assess the incidence of anti-YL201 antibodies

    Measured: Approximately within 36 months

  8. Evaluate the disease control rate (DCR) for patients assessed using RECIST version 1.1

    Approximately within 36 months

    Measured: DCR: defined as the proportion of patients who achieved a best overall response of CR, PR or stable disease (SD).

  9. Evaluate the duration of response (DoR) for patients assessed using RECIST version 1.1

    Approximately within 36 months

    Measured: DoR: defined as the time interval from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of PD. DoR will be assessed for patients with a response (CR or PR) only.

  10. Evaluate the time to response (TTR) for patients assessed using RECIST version 1.1

    TTR: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of objective response (CR or PR).

    Measured: Approximately within 36 months

  11. Evaluate the progression-free survival (PFS) for patients assessed using RECIST version 1.1

    PFS: defined as the time interval from the date of the first dose of study drug to the date of first documentation of PD or death due to any cause, whichever occurs first.

    Measured: Approximately within 36 months

  12. Evaluate the overall survival (OS) for patients

    OS: defined as the time interval from the date of the first dose of study drug to the date of death due to any cause.

    Measured: Approximately within 36 months

  13. Evaluate the radiographic progression-free survival (rPFS) for patients with prostate cancer

    Measured: Approximately within 36 months

  14. Evaluate the time to PSA progression (TTPP) for patients with prostate cancer

    Defined as the time from the first investigational drug administration to the first recording of PSA progression.

    Measured: Approximately within 36 months

  15. Evaluate the PSA duration of response (PDoR) for patients with prostate cancer

    Defined as the time from PSA reduction of ≥50% compared with baseline to PSA progression.

    Measured: Approximately within 36 months

  16. Evaluate the best PSA response for patients with prostate cancer

    Defined as the maximum percentage of PSA changes at any time during the study.

    Measured: Approximately within 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start22 Sep 2023
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
990 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06057922
Sponsor's protocol ID
YL201-CN-101-01
Status last verified
Mar 2026
First submitted
21 Sep 2023
Last updated
12 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 40082695

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing YL201 for Injection in people with Advanced Solid Tumor, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 52 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06057922, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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