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)
Evaluate the occurrence of DLTs during the first cycle in Part 1 — 21 days of Cycle 1
Evaluate the AEs in Part 2 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment — 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 — Approximately 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 1.1 — Approximately 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 2 — 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 — 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 — At the end of cycle 1 (each cycle is 21 days)
Trial sites (45)
Facility
City
Region
Status
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
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.
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