Phase
Condition
Neoplasms
Treatment
YL201 and atezolizumab
YL201
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed of the trial before the start of the trial and voluntarily sign their nameand 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 formof contraception and not donate, or retrieve for their own use, ova from the time ofscreening and throughout the study period, and for at least 5 months after the lastdose 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 notfreeze 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 inSolid Tumors (RECIST) version 1.1.
Pathologically confirmed diagnosis of an advanced solid tumor (SCLC, mCRPC, ESCC andNSCLC are preferred) for which standard treatment had proven to be ineffective orintolerable, or no standard treatment is available. For ES-SCLC patients in Arm C:no prior anti-cancer treatment
Exclusion
Exclusion Criteria:
Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of aninterventional study
Prior systemic anticancer treatment including chemotherapy, molecular -targetedtherapy, hormonal therapy, immunotherapy, or biological therapy within 3 weeksbefore the first dose of study drug (use of oral fluorouracil [eg, tegafur andcapecitabine] or small molecular-targeted therapy within 2 weeks or 5 half-lifeperiods [whichever is shorter]before the first dose; use of mitomycin ornitrosoureas within 6 weeks before the first dose; use of herbal medicine withantitumor indications or nonspecific immunomodulators [eg, thymosin, interferon, andinterleukin] 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 stereotacticradiation therapy without abdominal, within 2 weeks)
Undergone major surgery (not including diagnostic surgery) within 4 weeks before thefirst dose of study drug or expect major surgery during the study
Undergone allogeneic hematopoietic stem cell transplantation (HSCT) before the firstdose of study drug, or autologous HSCT within 3 months before the first dose ofstudy drug
Received systemic steroids (>10 mg/day of prednisone or its equivalent) or otherimmunosuppressive 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 orintend 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 isdefined 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 aspositive hepatitis C antibody and HCV RNA level above ULN at the study site
Unresolved toxicities from previous anticancer therapy, defined as toxicities (otherthan alopecia and pigmentation) not yet resolved to NCI CTCAE Grade ≤1, baseline, orthe level specified in the inclusion/exclusion criteria. Patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication maybe enrolled after discussion with the sponsor
A history of severe hypersensitivity reactions to the drug substances, inactiveingredients in the drug product, or other mAbs
Women who are breastfeeding or pregnant as confirmed by pregnancy tests performedwithin 7 days before the first dose
Study Design
Connect with a study center
Cross Cancer Institute - Alberta Health Services; Siu Chung Chu Professional Corporation
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
020
Edmonton 5946768, Alberta 5883102 T6G 1Z2
CanadaActive - Recruiting
021
Kelowna 5990579, British Columbia 5909050 V1Y 1E2
CanadaActive - Recruiting
022
Brampton 5907364, Ontario 6093943 L6R 3J7
CanadaActive - Recruiting
023
Toronto 6167865, Ontario 6093943 M5G 2C4
CanadaActive - Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510000
ChinaSite Not Available
024
Guangzhou 1809858, Guangdong 1809935 510000
ChinaCompleted
Henan Cancer Hospital
Zhengzhou, Henan 450003
ChinaSite Not Available
025
Zhengzhou 1784658, Henan 1808520 450003
ChinaCompleted
CHU de Bordeaux - Hopital Saint Andre
Bordeaux, 33000
FranceSite Not Available
026
Bordeaux 3031582, 33000
FranceActive - Recruiting
Centre Georges-Francois Leclerc
Dijon, 21000
FranceSite Not Available
027
Dijon 3021372, 21000
FranceActive - Recruiting
APHM - Hopital Nord
Marseille, 13915
FranceSite Not Available
028
Marseille 2995469, 13005
FranceActive - Recruiting
CHU de Nantes
Nantes, 44093
FranceSite Not Available
029
Nantes 2990969, 44093
FranceSite Not Available
Institut Curie - Site Paris
Paris, 75248
FranceSite Not Available
030
Paris 2988507, 75248
FranceSite Not Available
CHU de Poitiers
Poitiers, 86000
FranceSite Not Available
031
Poitiers 2986495, 86021
FranceActive - Recruiting
Institut de cancerologie de l'Ouest - Site Saint Herblain
Saint-Herblain, 44800
FranceSite Not Available
032
Saint-Herblain 2979590, 44800
FranceSite Not Available
Hopital Foch
Suresnes, 92150
FranceSite Not Available
033
Suresnes 2973675, 92150
FranceActive - Recruiting
Europejskie Centrum Zdrowia Otwock Sp. z.o.o.
Otwock, 05-400
PolandSite Not Available
044
Otwock 762788, 05-400
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569
PolandSite Not Available
045
Poznan 3088171, 60-569
PolandSite Not Available
034
Barcelona 3128760, Barcelona 08023
SpainActive - Recruiting
035
Barcelona 3128760, Barcelona 08025
SpainActive - Recruiting
Hospital Universitario Severo Ochoa
Leganes, Madrid 28911
SpainSite Not Available
START Madrid - Hospital Universitario Fundacion Jimenez Diaz
Moncloa-Aravaca, Madrid 28040
SpainSite Not Available
NEXT Oncology Madrid
Pozuelo de Alarcon, Madrid 28223
SpainSite Not Available
Hospital Universitario 12 de Octubre
Usera, Madrid 28041
SpainSite Not Available
039
Leganés 3118594, Madrid 3117732 28911
SpainSite Not Available
036
Madrid 3117735, Madrid 3117732 28050
SpainActive - Recruiting
037
Madrid 3117735, Madrid 3117732 28034
SpainActive - Recruiting
038
Moncloa-Aravaca 6544099, Madrid 3117732 28040
SpainActive - Recruiting
041
Pozuelo de Alarcón 3112989, Madrid 3117732 28223
SpainActive - Recruiting
042
Usera 6544490, Madrid 3117732 28041
SpainActive - Recruiting
Clinica Universidad de Navarra
Pamplona, Navarra 31008
SpainSite Not Available
040
Pamplona 3114472, Navarre 3115609 31008
SpainActive - Recruiting
043
Valencia 2509954, Valencia 2593113 46010
SpainActive - Recruiting
Hospital de la Santa creu i Sant Pau
Barcelona, 08025
SpainSite Not Available
NEXT Oncology. Phase I Unit / IOB - Hospital Quironsalud Barcelona
Barcelona, 08023
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainSite Not Available
START Madrid - Centro Integral Oncologico Clara Campal (CIOCC) - Hospital Universitario HM Sanchinarro
Madrid, 28050
SpainSite Not Available
Hospital Clinico Universitario de Valencia
Valencia, 46010
SpainSite Not Available
University California San Diego Moores Cancer Center
La Jolla, California 92093-0698
United StatesSite Not Available
002
Fair Oaks 5347287, California 5332921 95628
United StatesActive - Recruiting
001
La Jolla 5363943, California 5332921 92093-0698
United StatesActive - Recruiting
003
Lone Tree 5429208, Colorado 5417618 80124
United StatesActive - Recruiting
Georgetown University Medical Center
Washington, District of Columbia 20007
United StatesSite Not Available
004
Washington D.C. 4140963, District of Columbia 4138106 20007
United StatesActive - Recruiting
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida 34952
United StatesSite Not Available
Hematology Oncology Associates of the Treasure Coast
Port St. Lucie, Florida 34952
United StatesSite Not Available
Community Health Network
Indianapolis, Indiana 46250
United StatesSite Not Available
Mass General Cancer Center: Hematology
Boston, Massachusetts 02114
United StatesSite Not Available
005
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
University of Michigan - Rogel Cancer Center - Urology Oncology Clinic
Detroit, Michigan 48201-2013
United StatesSite Not Available
006
Ann Arbor 4984247, Michigan 5001836 48109
United StatesActive - Recruiting
007
Detroit 4990729, Michigan 5001836 48292
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St Louis, Missouri 63110
United StatesSite Not Available
008
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
CHRISTUS St. Vincent Health System - CHRISTUS St. Vincent Regional Cancer Center (Andrea Teague)
Santa Fe, New Mexico 87505-699
United StatesSite Not Available
009
Santa Fe 5490263, New Mexico 5481136 87505-699
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
010
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
University of North Carolina
Chapel Hill, North Carolina 27514
United StatesSite Not Available
011
Chapel Hill 4460162, North Carolina 4482348 27514
United StatesActive - Recruiting
012
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
NEXT Oncology-Dallas
Dallas, Texas 75231
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
NEXT Oncology
San Antonio, Texas 78229
United StatesSite Not Available
NEXT San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
UT Health East Texas HOPE Cancer Center
Tyler, Texas 75701
United StatesSite Not Available
014
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
015
Irving 4700168, Texas 4736286 75039
United StatesActive - Recruiting
013
San Antonio 4726206, Texas 4736286 78229
United StatesActive - Recruiting
016
Tyler 4738214, Texas 4736286 75701
United StatesActive - Recruiting
Inova Schar Cancer Institute - Inova Fairfax Hospital Location
Fairfax, Virginia 22031
United StatesSite Not Available
017
Fairfax 4758023, Virginia 6254928 22031
United StatesActive - Recruiting
Medical Oncology Associates and Summit Cancer Centers
Spokane, Washington 99208
United StatesSite Not Available
Northwest Medical Specialties
Tacoma, Washington 98405
United StatesSite Not Available
018
Spokane 5811696, Washington 5815135 99208
United StatesActive - Recruiting
019
Tacoma 5812944, Washington 5815135 98405
United StatesActive - Recruiting

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