🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05434234
Recruiting Phase 1/2

A Study of YL201 in Patients With Advanced Solid Tumors

NCT05434234 · tracked via the Priya Life Science China tracker
Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Phase
Phase 1/2
Started
2022-05-25
Last updated
2026-06-22

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

YL201YL201YL201 and atezolizumab

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (45)

FacilityCityRegionStatus
002 Fair Oaks California Recruiting
001 La Jolla California Recruiting
003 Lone Tree Colorado Recruiting
004 Washington D.C. District of Columbia Recruiting
005 Boston Massachusetts Recruiting
006 Ann Arbor Michigan Recruiting
007 Detroit Michigan Recruiting
008 St Louis Missouri Recruiting
009 Santa Fe New Mexico Recruiting
010 New York New York Recruiting
011 Chapel Hill North Carolina Recruiting
012 Nashville Tennessee Recruiting
014 Houston Texas Recruiting
015 Irving Texas Recruiting
013 San Antonio Texas Recruiting
016 Tyler Texas Recruiting
017 Fairfax Virginia Recruiting
018 Spokane Washington Recruiting
019 Tacoma Washington Recruiting
020 Edmonton Alberta Recruiting
021 Kelowna British Columbia Recruiting
022 Brampton Ontario Recruiting
023 Toronto Ontario Recruiting
024 Guangzhou Guangdong Completed
025 Zhengzhou Henan Completed
026 Bordeaux France Recruiting
027 Dijon France Recruiting
028 Marseille France Recruiting
029 Nantes France Not Yet Recruiting
030 Paris France Not Yet Recruiting
031 Poitiers France Recruiting
032 Saint-Herblain France Not Yet Recruiting
033 Suresnes France Recruiting
044 Otwock Poland Recruiting
045 Poznan Poland Not Yet Recruiting
034 Barcelona Barcelona Recruiting
035 Barcelona Barcelona Recruiting
039 Leganés Madrid Not Yet Recruiting
037 Madrid Madrid Recruiting
036 Madrid Madrid Recruiting

+ 5 more sites — see the full list on the official registry below.

More MediLink Therapeutics (Suzhou) Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05434234 on ClinicalTrials.gov ↗ ← All trials in China