A Study of YL201 in Patients With Advanced Solid Tumors

{ "A Study of YL201 for Advanced Solid Tumors", "This study is testing a new drug called YL201 for people with advanced solid tumors that haven't responded to other treatments or for which no standard treatment exists. It's a first-in-human study, meaning it's the first time YL201 is being given to people. The study has two parts: first, to find the safest and most effective dose of YL201, and then to further evaluate its safety and how well it works in specific types of advanced solid tumors. Some patients will receive YL201 alone, while others will receive YL201 with another drug called atezolizumab. The study is looking at side effects, how well the drug works (especially for prostate cancer), and how long these effects last. You may be able to join if you are at least 18 years old, have a good general health status, and meet other health requirements. This study is currently unclear on its recruitment status and plans to enroll 312 people.", "design": "This is a Phase 1, open-label study, meaning you and your doctors will know which treatment you are receiving. It is a first-in-human study and plans to enroll 312 participants.", "commitments": "You will receive YL201 as an intravenous (IV) infusion once every three weeks. Some participants will also receive atezolizumab. The study will monitor side effects and responses for approximately 36 months.", "compensation": "Not stated in the trial record.", "follow_up": "The study will evaluate side effects and prostate-specific antigen (PSA) response for approximately 36 months.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

A Study of YL201 in Patients With Advanced Solid Tumors

Recruiting

PHASE1Ages 18+InterventionalTreatment

MediLink Therapeutics (Suzhou) Co., Ltd.

~312 participants

Updated 2026-06-22 on ClinicalTrials.gov

What's tested:YL201YL201 and atezolizumab

At a glance

Recruiting sites

38 of 45 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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

Measured over 21 days of Cycle 1

+6 more outcomes measured

Conditions

Advanced Solid Tumor

Where it's being run

45 sites across 24 states

France8

Madrid6

Texas4

California2

Michigan2

Washington2

Ontario2

Poland2

Who to contact

Sasha Stann

[email protected]

617-240-8494

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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

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

Exclusion

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

What this trial measures

Evaluate the occurrence of DLTs during the first cycle in Part 121 days of Cycle 1
Evaluate the AEs in Part 2 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatmentBy the global end of trial date, approximately within 36 months
Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer in Part 2Approximately within 36 months
PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline
Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 2, assessed using RECIST version 1.1Approximately within 36 months
ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).
Laboratory abnormalities as characterized by type, frequency, severity, and timing in Part 2Biy the end of trial date, approximately within 36 months
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 3Biy the end of trial date, approximately within 36 months
Nature and frequency of dose-limiting toxicities (DLTs), incidence, nature, and severity of laboratory abnormalities in Part 3At the end of cycle 1 (each cycle is 21 days)

Trialytics