Recruiting
Phase 1
Phase 2

YL201

Sponsor:

MediLink Therapeutics (Suzhou) Co., Ltd.

Code:

NCT05434234

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

YL201

YL201

YL201 and atezolizumab

Study Details

Brief 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).

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.

Conditions

Advanced Solid Tumor

Study ID

NCT05434234

Start date

May 25, 2022

Status verified date

Nov, 2025

Completion date

Oct 6, 2027

Anticipated

Primary completion date

Apr 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

312 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose escalation

All participants enrolled in the dose escalation part

experimental: Dose expansion

All participants enrolled in the dose expansion part

experimental: Dose Selection

Interventions

YL201

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

YL201

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 atezolizumab

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

Primary outcome measure

  • Evaluate the occurrence of DLTs during the first cycle in Part 1 [ Time Frame: 21 days of Cycle 1 ]
  • Evaluate the AEs in Part 2 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment [ Time Frame: By 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 2 [ Time Frame: Approximately within 36 months ]
  • Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 2, assessed using RECIST version 1.1 [ Time Frame: Approximately within 36 months ]
  • Laboratory abnormalities as characterized by type, frequency, severity, and timing in Part 2 [ Time Frame: Biy 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 3 [ Time Frame: Biy 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 3 [ Time Frame: At the end of cycle 1 (each cycle is 21 days) ]

Central Contacts and Locations

Central contacts

Sasha Stann

617-240-8494info@medilinkthera.com

Alan Xu, Ph.D.

617-871-9455info@medilinkthera.com

Locations

002

Recruiting

Fair Oaks, California, United States, 95628

001

Recruiting

La Jolla, California, United States, 92093-0698

003

Recruiting

Lone Tree, Colorado, United States, 80124

004

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Washington D.C., District of Columbia, United States, 20007

005

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Boston, Massachusetts, United States, 02114

006

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Ann Arbor, Michigan, United States, 48109

007

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Detroit, Michigan, United States, 48292

008

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St Louis, Missouri, United States, 63110

009

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Santa Fe, New Mexico, United States, 87505-699

010

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New York, New York, United States, 10029

011

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Chapel Hill, North Carolina, United States, 27514

012

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Nashville, Tennessee, United States, 37203

014

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Houston, Texas, United States, 77030

015

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Irving, Texas, United States, 75039

013

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San Antonio, Texas, United States, 78229

016

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Tyler, Texas, United States, 75701

017

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Fairfax, Virginia, United States, 22031

018

Recruiting

Spokane, Washington, United States, 99208

019

Recruiting

Tacoma, Washington, United States, 98405

020

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Edmonton, Alberta, Canada, T6G 1Z2

021

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Kelowna, British Columbia, Canada, V1Y 1E2

022

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Brampton, Ontario, Canada, L6R 3J7

023

Recruiting

Toronto, Ontario, Canada, M5G 2C4

More Information

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Last update posted

Jun 22, 2026

Last verified

Nov, 2025

Keywords

  • Antibody-drug conjugate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MediLink Therapeutics (Suzhou) Co., Ltd. on 2026-06-22.