A Study of YL201 in Patients With Advanced Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor

In brief

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.

Key facts

Study ID: NCT05434234
Run by: MediLink Therapeutics (Suzhou) Co., Ltd.
People needed: 312
Starts: 2022-05-25
Expected to finish: 2027-10-06
Last updated by the study team: 2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

043 — Valencia, Valencia, Spain (enrolling)
001 — La Jolla, California, United States (enrolling)
003 — Lone Tree, Colorado, United States (enrolling)
004 — Washington D.C., District of Columbia, United States (enrolling)
005 — Boston, Massachusetts, United States (enrolling)
006 — Ann Arbor, Michigan, United States (enrolling)
007 — Detroit, Michigan, United States (enrolling)
008 — St Louis, Missouri, United States (enrolling)
009 — Santa Fe, New Mexico, United States (enrolling)
010 — New York, New York, United States (enrolling)
011 — Chapel Hill, North Carolina, United States (enrolling)
012 — Nashville, Tennessee, United States (enrolling)
014 — Houston, Texas, United States (enrolling)
015 — Irving, Texas, United States (enrolling)
013 — San Antonio, Texas, United States (enrolling)
016 — Tyler, Texas, United States (enrolling)
017 — Fairfax, Virginia, United States (enrolling)
018 — Spokane, Washington, United States (enrolling)
019 — Tacoma, Washington, United States (enrolling)
020 — Edmonton, Alberta, Canada (enrolling)
021 — Kelowna, British Columbia, Canada (enrolling)
022 — Brampton, Ontario, Canada (enrolling)
023 — Toronto, Ontario, Canada (enrolling)
037 — Madrid, Madrid, Spain (enrolling)
036 — Madrid, Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.