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Advanced Solid TumorPhase 1/2NCT05434234

A Study of YL201 in Patients With Advanced Solid Tumors

A Phase 1/2 study testing YL201 and YL201 and atezolizumab in people with Advanced Solid Tumor, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 45 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201 conducted in China and the United States. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
YL201 and YL201 and atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
45 sitesin 6 countries
Study dates
25 May 2022to 6 Oct 2027
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 years and older
  • 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
  • Aged ≥18 years
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
  • Adequate organ and bone marrow function
  • Female patients of childbearing potential must agree to use a highly effective form of contraception and not donate, or retrieve for their own use, ova from the time of screening and throughout the study period, and for at least 5 months after the last dose of atezolizumab or 6 months after the last dose of YL201, whichever is later. Male patients must agree to use a highly effective form of contraception and not freeze or donate sperm from the time of screening and throughout the study period, and for at least 6 months after the last dose of YL201.
  • Life expectancy of ≥3 months
Show all 9Show fewer
  • Able and willing to comply with protocol visits and procedures
  • Have at least 1 evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Pathologically confirmed diagnosis of an advanced solid tumor (SCLC, mCRPC, ESCC and NSCLC are preferred) for which standard treatment had proven to be ineffective or intolerable, or no standard treatment is available. For ES-SCLC patients in Arm C: no prior anti-cancer treatment

Who cannot join

  • Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study
  • Prior systemic anticancer treatment including chemotherapy, molecular -targeted therapy, hormonal therapy, immunotherapy, or biological therapy within 3 weeks before the first dose of study drug (use of oral fluorouracil [eg, tegafur and capecitabine] or small molecular-targeted therapy within 2 weeks or 5 half-life periods [whichever is shorter]before the first dose; use of mitomycin or nitrosoureas within 6 weeks before the first dose; use of herbal medicine with antitumor indications or nonspecific immunomodulators [eg, thymosin, interferon, and interleukin] within 2 weeks before the first dose).
  • Prior radiation therapy, including palliative stereotactic radiation with abdominal, within 4 weeks before the first dose of study drug (if palliative stereotactic radiation therapy without abdominal, within 2 weeks)
  • Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study
  • Undergone allogeneic hematopoietic stem cell transplantation (HSCT) before the first dose of study drug, or autologous HSCT within 3 months before the first dose of study drug
  • Received systemic steroids (>10 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks before the first dose of study drug. Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study
Show all 11Show fewer
  • Known human immunodeficiency virus (HIV) infection
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Active HBV is defined as hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) positive, and HBV DNA level above ULN at the study site; active HCV is defined as positive hepatitis C antibody and HCV RNA level above ULN at the study site
  • Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and pigmentation) not yet resolved to NCI CTCAE Grade ≤1, baseline, or the level specified in the inclusion/exclusion criteria. Patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be enrolled after discussion with the sponsor
  • A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other mAbs
  • Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 7 days before the first dose

Trial locations and contacts

45 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Sasha Stann contact

617-240-8494

info@medilinkthera.com

Alan Xu, Ph.D. contact

617-871-9455

info@medilinkthera.com

45 sites in 6 countries

United States19 sites, 19 recruiting

  • 006

    Ann Arbor, Michigan, 48109

    Study Coordinator

    Recruiting

  • 005

    Boston, Massachusetts, 02114

    Study Coordinator

    Recruiting

  • 011

    Chapel Hill, North Carolina, 27514

    Study Coordinator

    Recruiting

  • 007

    Detroit, Michigan, 48292

    Study Coordinator

    Recruiting

  • 002

    Fair Oaks, California, 95628

    Study Coordinator

    Recruiting

  • 017

    Fairfax, Virginia, 22031

    Study Coordinator

    Recruiting

  • 014

    Houston, Texas, 77030

    Site Coordinator

    Recruiting

  • 015

    Irving, Texas, 75039

    Study Coordinator

    Recruiting

  • 001

    La Jolla, California, 92093-0698

    Study Coordinator

    Recruiting

  • 003

    Lone Tree, Colorado, 80124

    Study Coordinator

    Recruiting

  • 012

    Nashville, Tennessee, 37203

    Study Coordinator

    Recruiting

  • 010

    New York, New York, 10029

    Study Coordinator

    Recruiting

  • 013

    San Antonio, Texas, 78229

    Site Coordinator

    Recruiting

  • 009

    Santa Fe, New Mexico, 87505-699

    Study Coordinator

    Recruiting

  • 018

    Spokane, Washington, 99208

    Study Coordinator

    Recruiting

  • 008

    St Louis, Missouri, 63110

    Study Coordinator

    Recruiting

  • 019

    Tacoma, Washington, 98405

    Study Coordinator

    Recruiting

  • 016

    Tyler, Texas, 75701

    Study Coordinator

    Recruiting

  • 004

    Washington D.C., District of Columbia, 20007

    Study Coordinator

    Recruiting

Other trials in United States

Spain10 sites, 10 recruiting

  • 034

    Barcelona, Barcelona, 08023

    Study Coordinator

    Recruiting

  • 035

    Barcelona, Barcelona, 08025

    Study Coordinator

    Recruiting

  • 039

    Leganés, Madrid, 28911

    Study Coordinator

    Not yet recruiting

  • 037

    Madrid, Madrid, 28034

    Study Coordinator

    Recruiting

  • 036

    Madrid, Madrid, 28050

    Study Coordinator

    Recruiting

  • 038

    Moncloa-Aravaca, Madrid, 28040

    Study Coordinator

    Recruiting

  • 040

    Pamplona, Navarre, 31008

    Study Coordinator

    Recruiting

  • 041

    Pozuelo de Alarcón, Madrid, 28223

    Study Coordinator

    Recruiting

  • 042

    Usera, Madrid, 28041

    Study Coordinator

    Recruiting

  • 043

    Valencia, Valencia, 46010

    Study Coordinator

    Recruiting

Other trials in Spain

France8 sites, 8 recruiting

  • 026

    Bordeaux, 33000

    Study Coordinator

    Recruiting

  • 027

    Dijon, 21000

    Study Coordinator

    Recruiting

  • 028

    Marseille, 13005

    Study Coordinator

    Recruiting

  • 029

    Nantes, 44093

    Study Coordinator

    Not yet recruiting

  • 030

    Paris, 75248

    Study Coordinator

    Not yet recruiting

  • 031

    Poitiers, 86021

    Study Coordinator

    Recruiting

  • 032

    Saint-Herblain, 44800

    Study Coordinator

    Not yet recruiting

  • 033

    Suresnes, 92150

    Study Coordinator

    Recruiting

Other trials in France

Canada4 sites, 4 recruiting

  • 022

    Brampton, Ontario, L6R 3J7

    Study Coordinator

    Recruiting

  • 020

    Edmonton, Alberta, T6G 1Z2

    Study Coordinator

    Recruiting

  • 021

    Kelowna, British Columbia, V1Y 1E2

    Study Coordinator

    Recruiting

  • 023

    Toronto, Ontario, M5G 2C4

    Study Coordinator

    Recruiting

Other trials in Canada

China2 sites

  • 024

    Guangzhou, Guangdong, 510000

    Completed

  • 025

    Zhengzhou, Henan, 450003

    Completed

Other trials in China

Poland2 sites, 2 recruiting

  • 044

    Otwock, 05-400

    Study Coordinator

    Recruiting

  • 045

    Poznan, 60-569

    Study Coordinator

    Not yet recruiting

Other trials in Poland

About this study

Official title: A Phase 1A/1B, Multicenter, Nonrandomized, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL201 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors

This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201 conducted in China and the United States. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2).

Part 1 will estimate the MTD/RED(s) in dose escalation cohorts of patients with advanced solid tumors unresponsive to currently available therapies or for whom no standard therapy is available.

Part 2 will include patients with selected advanced solid tumor types enrolled at the MTD/RED(s), to better define the safety profile and evaluate the efficacy of YL201.

Being tested
YL201, YL201 and atezolizumab
Keywords
Antibody-drug conjugate

What participants receive

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

  • YL201Drug

    Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle.

  • YL201Drug

    Patients will be treated with YL201 intravenous (IV) (A mg/kg or B g/kg infusion once every 3 weeks (Q3W) as a cycle.

  • YL201 and atezolizumabDrug

    Patients will be treated with YL201 intravenous (IV) infusion (A mg/kg or B mg/kg, up to 200mg) followed by atezolizumab on day 1 of each 21 day cycle

Study groups in NCT05434234
Study groupRoleWhat they receive
Dose escalationExperimentalAll participants enrolled in the dose escalation part
Receives: Drug: YL201
Dose expansionExperimentalAll participants enrolled in the dose expansion part
Receives: Drug: YL201
Dose SelectionExperimentalNot described
Receives: Drug: YL201 and atezolizumab

What is being measured

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

  1. Evaluate the occurrence of DLTs during the first cycle in Part 1

    Measured: 21 days of Cycle 1

  2. Evaluate the AEs in Part 2 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

  3. Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer in Part 2

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

    Measured: Approximately within 36 months

  4. Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 2, 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: Approximately within 36 months

  5. Laboratory abnormalities as characterized by type, frequency, severity, and timing in Part 2

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

  6. Incidence, nature, and severity of AEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V5.0 in Part 3

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

  7. Nature and frequency of dose-limiting toxicities (DLTs), incidence, nature, and severity of laboratory abnormalities in Part 3

    Measured: At the end of cycle 1 (each cycle is 21 days)

Secondary outcomes (18)

  1. Evaluate the AEs in Part 1 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. Characterize the PK parameter AUC

    Measured: Approximately within 36 months

  3. Characterize the PK parameter Cmax

    Measured: Approximately within 36 months

  4. Characterize the PK parameter Ctrough

    Measured: Approximately within 36 months

  5. Characterize the PK parameter CL

    Measured: Approximately within 36 months

  6. Characterize the PK parameter Vd

    Measured: Approximately within 36 months

  7. Characterize the PK parameter t1/2

    Measured: Approximately within 36 months

  8. Assess the incidence of anti-YL201 antibodies

    Measured: Approximately within 36 months

  9. Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer in Part 1

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

    Measured: Approximately within 36 months

  10. Evaluate the PSA progression-free survival (PSA-PFS) for patients with prostate cancer

    PSA-PFS: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of PSA progression, based on PCWG3 criteria.

    Measured: Approximately within 36 months

  11. Evaluate the radiological PFS (rPFS) for patients with prostate cancer

    rPFS: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of radiographic tumor progression or death due to any cause, whichever occurs first, based on RECIST 1.1 and PCWG3 criteria.

    Measured: Approximately within 36 months

  12. Evaluate the failure-free survival (FFS) for patients with prostate cancer

    FFS: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of radiographic tumor progression, unequivocal clinical progression, PSA progression or death due to disease progression, whichever occurs first.

    Measured: Approximately within 36 months

  13. Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 1, Part 2, and Part 3, 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: Approximately within 36 months

  14. Evaluate the disease control rate (DCR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1

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

    Measured: Approximately within 36 months

  15. Evaluate the duration of response (DoR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1

    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.

    Measured: Approximately within 36 months

  16. Evaluate the time to response (TTR) for patients with solid tumors other than prostate cancer, 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

  17. Evaluate the progression-free survival (PFS) for patients with solid tumors other than prostate cancer, 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

  18. Evaluate the overall survival (OS) for patients with solid tumors

    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

Timeline

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

  1. First posted27 Jun 2022
  2. Study start25 May 2022
  3. Primary completion6 Apr 2027 (estimated)
  4. Study completion6 Oct 2027 (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
Sequential
Masking
None (open label)
Enrolment
312 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05434234
Sponsor's protocol ID
YL201-INT-101-01
Status last verified
Nov 2025
First submitted
16 Jun 2022
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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 and YL201 and atezolizumab in people with Advanced Solid Tumor, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 45 sites in 6 countries.

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 11 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: looking for participants now, as of the sponsor's last update on 22 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 45 sites in United States, Spain, France, Canada, China and 1 more country. 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?

Contact Sasha Stann (617-240-8494, info@medilinkthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the occurrence of DLTs during the first cycle in Part 1 (time frame: 21 days of Cycle 1). The study lists 7 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 NCT05434234, 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 22 Jun 2026.

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