Testing YL201 in patients with advanced solid tumors
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
Run by MediLink Therapeutics (Suzhou) Co., Ltd. · NCT05434234 · Data updated 2026-11-12
This study is testing a new treatment called YL201 in people with advanced solid tumors that haven't responded to other treatments to see how well it works and what dose is safe.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 312 (estimated) |
| Sponsor | MediLink Therapeutics (Suzhou) Co., Ltd. Industry-sponsored |
| Drugs / interventions | atezolizumab, chemotherapy, immunotherapy, radiation, prednisone |
| Locations | 45 sites (Fair Oaks, California and 44 other locations) |
| Status | Recruiting |
| Started | May 25, 2022 |
| Main results expected | April 6, 2027 |
| Study ends | October 6, 2027 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT05434234 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with advanced solid tumors that are unresponsive to standard treatments.
✕Probably not a fit
Patients with solid tumors that are responsive to existing therapies or those with a life expectancy of less than three months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 1, multicenter, nonrandomized, open-label study evaluates YL201, an antibody-drug conjugate, in patients with advanced solid tumors that have not responded to existing therapies. The trial consists of two parts: the first part focuses on dose escalation to determine the maximum tolerated dose (MTD), while the second part involves a dose expansion to further assess safety and efficacy in specific tumor types. The study is being conducted in both China and the United States.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that currently have limited or no effective therapies.
How similar studies have gone: Other studies involving antibody-drug conjugates have shown promise in treating advanced solid tumors, indicating potential for success with this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
Where it's running
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002
Fair Oaks, California, United States Recruiting -
001
La Jolla, California, United States Recruiting -
003
Lone Tree, Colorado, United States Recruiting -
004
Washington D.C., District of Columbia, United States Recruiting -
005
Boston, Massachusetts, United States Recruiting -
006
Ann Arbor, Michigan, United States Recruiting
Show 39 more locations
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007
Detroit, Michigan, United States Recruiting -
008
St Louis, Missouri, United States Recruiting -
009
Santa Fe, New Mexico, United States Recruiting -
010
New York, New York, United States Recruiting -
011
Chapel Hill, North Carolina, United States Recruiting -
012
Nashville, Tennessee, United States Recruiting -
014
Houston, Texas, United States Recruiting -
015
Irving, Texas, United States Recruiting -
013
San Antonio, Texas, United States Recruiting -
016
Tyler, Texas, United States Recruiting -
017
Fairfax, Virginia, United States Recruiting -
018
Spokane, Washington, United States Recruiting -
019
Tacoma, Washington, United States Recruiting -
020
Edmonton, Alberta, Canada Recruiting -
021
Kelowna, British Columbia, Canada Recruiting -
022
Brampton, Ontario, Canada Recruiting -
023
Toronto, Ontario, Canada Recruiting -
026
Bordeaux, France Recruiting -
027
Dijon, France Recruiting -
028
Marseille, France Recruiting -
031
Poitiers, France Recruiting -
033
Suresnes, France Recruiting -
044
Otwock, Poland Recruiting -
034
Barcelona, Barcelona, Spain Recruiting -
035
Barcelona, Barcelona, Spain Recruiting -
037
Madrid, Madrid, Spain Recruiting -
036
Madrid, Madrid, Spain Recruiting -
038
Moncloa-Aravaca, Madrid, Spain Recruiting -
041
Pozuelo de Alarcón, Madrid, Spain Recruiting -
042
Usera, Madrid, Spain Recruiting -
040
Pamplona, Navarre, Spain Recruiting -
043
Valencia, Valencia, Spain Recruiting -
024
Guangzhou, Guangdong, China Completed -
025
Zhengzhou, Henan, China Completed -
029
Nantes, France Not yet recruiting -
030
Paris, France Not yet recruiting -
032
Saint-Herblain, France Not yet recruiting -
045
Poznan, Poland Not yet recruiting -
039
Leganés, Madrid, Spain Not yet recruiting
Study contacts
- Study coordinator: Sasha Stann
- Email: info@medilinkthera.com
- Phone: 617-240-8494
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-
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-
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-
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.