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Advanced Solid TumorsPhase 1NCT06394414

A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors

A Phase 1 study testing YL201 in people with Advanced Solid Tumors, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 25 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 phase 1, multicenter, open-label stydy to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy in Selected Subjects with Advanced Solid Tumors conducted in China. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
YL201
Could I receive a placebo?
No, everyone receives an active treatment
How many people
187 participants
Where
25 sitesChina
Study dates
17 Apr 2024to 29 Apr 2030
Phase
Phase 1
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

  • 1) Informed of the study before the start of the study and voluntarily sign their name and date on the informed consent form (ICF).
  • 2) Subjects will be enrolled in the dose-escalation phase: Advanced solid tumors, like NPC, SCLC and etc.
  • 3) Subjects will be enrolled in the dose-expansion phase: NPC, SCLC, NSCLC and other advanced cancer.
  • 4) According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, there must be at least one extracranial measurable lesion.
  • 5) Archived or fresh tumor tissue samples can be provided. 6) Within 7 days before the first dose, organ and bone marrow functions must meet the requirements.
  • 7) Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 by the United States of America standards.
  • 8) Female subjects of childbearing potential must agree to use highly effective contraception measures from screening throughout the duration of the study and for at least 6 months after the last dose of the study drug. Male subjects must agree to use highly effective contraception measures from screening throughout the duration of the study and for at least 6 months after the last dose of the study drug.
  • 9) Subjects with expected survival ≥ 3 months. 10) Capable and willing to comply with the study protocol's scheduled visits and procedures.

Who cannot join

  • 1) Suitable for local radical treatment. 2) Previous Drug therapy targeting B7H3. 3) Previous Drug therapy with topoisomerase I inhibitors or ADCs composed of topoisomerase I inhibitors.
  • 4) Prior treatment with anti-PD-(L)1, other immune checkpoint inhibitors, immune checkpoint agonists, or immunocellular therapies and other therapies targeting tumor immunity mechanisms.
  • 5) Toxicity from previous anticancer treatments has not resolved. 6) Concurrent enrollment in another clinical study. 7) Inadequate washout period for prior anticancer treatment before the first dose of study drug.
  • 8) Underwent major surgery (excluding diagnostic surgery) or suffered serious trauma.
  • 9) Received allogeneic stem cell or solid organ transplant. 10) Active autoimmune diseases requiring systemic treatment. 11) Received systemic steroids. 12) Metastases to meninges or carcinomatous meningitis. 13) Brain metastasis or spinal cord compression. 14) Uncontrolled or clinically significant cardiovascular disease. 15) Clinically significant concomitant pulmonary disease. 16) With uncontrolled third-space fluid. 17) History of gastrointestinal perforation and / or fistula within 6 months prior to the first dose.
  • 18) Serious Infection prior to the first dose. 19) Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Show all 9Show fewer
  • 20) Any other primary malignancy before the first dose of study drug. 21) A history of severe hypersensitivity reactions to the investigational product, inactive ingredients in the formulation, or other monoclonal antibodies.
  • 22) Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 3 days before the first dose.
  • 23) Any illness, medical condition, organ system dysfunction, or social situation.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

China25 sites

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijinig

  • The First Hospital of Jilin University

    Changhua, Jilin

  • Hunan Cancer Hospital

    Changsha, Hunan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Provincial Cancer Hospital

    Hangzhou, Zhejiang

  • Cancer Hospital Affiliated to Harbin Medical University

    Harbin, Heilongjiang

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

  • Linyi Central Hospital

    Linyi, Shandong

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Liaoning Provincial Cancer Hospital

    Shenyang, Liaoning

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • West China Hospital, Sichuan University

    Sichuan, Sichuan

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

  • Union Hospital Tongji Medical College HuaZhong University of Science Technology

    Wuhan, Hubei

  • Zaozhuang Municipal Hospital

    Zaozhuang, Shandong

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Serplulimab With or Without Platinum-based Chemotherapy in Selected Subjects With Advanced Solid Tumors

This is a phase 1, multicenter, open-label stydy to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy in Selected Subjects with Advanced Solid Tumors conducted in China. The study will include 2 parts: a dose escalation part (Part 1) followed by a cohort expansion part (Part 2).

Part 1 will estimate the safety, tolerability and MTD/RED(s) of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors.

Part 2 will estimate the efficacy of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors.

Being tested
YL201

What participants receive

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

  • YL201Drug

    Also called Serplulimab, Platinum

    YL201 (High dose, medium dose and low dose; Q3W) in Combination with Serplulimab (4.5mg/kg; Q3W) with or without Platinum(70 mg/m2; Q3W)-based Chemotherapy.

Study groups in NCT06394414
Study groupRoleWhat they receive
Part 1: Dose escalationExperimentalYL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy
Receives: Drug: YL201
Part2: Cohort ExpansionExperimentalYL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy
Receives: Drug: YL201

What is being measured

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

  1. Evaluate the AEs in YL201 combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors

    AE: Adverse Event

    Measured: Approximately within 36 months

  2. To determine the MTD/RED of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors

    maximum tolerated dose (MTD), recommended expansion dose (RED)

    Measured: Approximately within 36 months

  3. To evaluate the efficacy of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors based on ORR

    objective response rate (ORR)

    Measured: Approximately within 36 months

  4. To determine the RP2D of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors based on ORR

    recommended Phase 2 dose (RP2D)

    Measured: Approximately within 36 months

Secondary outcomes (14)

  1. To evaluate the AUC of YL201 combination therapy

    area under the curve (AUC)

    Measured: Approximately within 36 months

  2. To evaluate the Cmax of YL201 combination therapy

    peak concentration (Cmax)

    Measured: Approximately within 36 months

  3. To evaluate the Ctrough of YL201 combination therapy

    trough concentration (Ctrough)

    Measured: Approximately within 36 months

  4. To evaluate the CL of YL201 combination therapy

    clearance rate (CL)

    Measured: Approximately within 36 months

  5. To evaluate the Vd of YL201 combination therapy

    volume of distribution (Vd)

    Measured: Approximately within 36 months

  6. To evaluate the t1/2 of YL201 combination therapy

    half-life time (t1/2)

    Measured: Approximately within 36 months

  7. To evaluate the DpR of YL201 combination therapy

    depth of response (DpR); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Approximately within 36 months

  8. To evaluate the DCR of YL201 combination therapy

    disease control rate (DCR); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Approximately within 36 months

  9. To evaluate the DoR of YL201 combination therapy

    duration of response (DoR); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Approximately within 36 months

  10. To evaluate the TTR of YL201 combination therapy

    time to response (TTR); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Approximately within 36 months

  11. To evaluate the PFS of YL201 combination therapy

    progression-free survival (PFS); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Approximately within 36 months

  12. To evaluate the OS of YL201 combination therapy

    Overall survival (OS)

    Measured: Approximately within 36 months

  13. To evaluate the immunogenicity of YL201 combination therapy

    Incidence of anti-YL201 antibodies

    Measured: Approximately within 36 months

  14. To assess the expression level of B7H3 and PD-L1 in Tumor tissue

    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 posted1 May 2024
  2. Study start17 Apr 2024
  3. Primary completion29 Apr 2027 (estimated)
  4. Study completion29 Apr 2030 (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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06394414
Sponsor's protocol ID
YL201-CN-102-02
Status last verified
Jun 2026
First submitted
23 Apr 2024
Last updated
25 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YL201 in people with Advanced Solid Tumors, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 25 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 8 inclusion and 9 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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 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.

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 in YL201 combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors (time frame: Approximately within 36 months). The study lists 4 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 NCT06394414.

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 25 Jun 2026.

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Clinical Trial NCT06394414 | AzTrials