Phase
Condition
Neoplasms
Treatment
ZL-1218
Pembrolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult men and women ≥ 18 years of age. If 18 years is not the age of majority, thenadult men and women ≥ age of majority per local regulation.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Life expectancy > 12 weeks.
Subjects must have histologically confirmed and documented diagnosis of locallyadvanced unresectable or metastatic advanced solid tumor that is refractory tostandard treatment, or intolerant to standard treatment, or for which no standardtreatment exists.Subjects must have at least one target lesion as defined by RECISTv1.1 on CT, PET/CT, or MRI scan.
Subjects must have a site of disease which is not previously irradiated and is safeand amenable to biopsy per the treating institution's guidelines. Subjects must bewilling to undergo a tumor biopsy at screening and on treatment, per the protocolguidelines.
Subjects must have a site of disease which is not previously irradiated and is safeand amenable to biopsy per the treating institution's guidelines. Subjects must bewilling to undergo a tumor biopsy at screening and on treatment, per the protocolguidelines.
Exclusion
Exclusion Criteria:
Symptomatic or uncontrolled brain metastasis requiring concurrent treatment,inclusive of but not limited to surgery, radiation, and/or corticosteroids.
Prior exposure to CCR8 inhibitor (anti-CCR8 antibody) or hypersensitivity to anyingredient of the study drug.
Out of range value within 10 days prior to the first dose of study treatment.
Subjects have received a live or live-attenuated vaccine within 30 days of plannedstart of study therapy.
Subjects with known history of, or any evidence of active, non-infectiouspneumonitis.
Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study drug.
Treatment with any systemic anti-cancer treatment (including investigationalproducts) within 4 weeks before first dose of study drug.
Non-palliative radiotherapy within 2 weeks prior to first dose of study drug or havehad history of radiation pneumonitis.
Major surgery within 4 weeks of the first dose of study drug.
Infections requiring systemic antibiotic therapy.
Any medical conditions that would, in the investigator's judgement, prevent thesubject's participation in the clinical study due to safety concerns, compliancewith the study procedures, or interpretation of the study results.
Study Design
Connect with a study center
Zai Lab Site 1002
Hangzhou, 310009
ChinaSite Not Available
Zai Lab Site 1002
Hangzhou 1808926, 310009
ChinaSite Not Available
Zai Lab Site 1001
Shanghai, 200123
ChinaSite Not Available
Zai Lab Site 1001
Shanghai 1796236, 200123
ChinaSite Not Available
Zai Lab Site 8001
Barcelona 3128760, Barcelona 8035
SpainSite Not Available
Zai Lab Site 8005
Barcelona 3128760, Barcelona 8023
SpainSite Not Available
Zai Lab Site 8004
Pozuelo De Alarcón, Madrid 28223
SpainSite Not Available
Zai Lab Site 8007
Madrid 3117735, Madrid 3117732 28040
SpainSite Not Available
Zai Lab Site 8008
Madrid 3117735, Madrid 3117732 28050
SpainSite Not Available
Zai Lab Site 8004
Pozuelo de Alarcón 3112989, Madrid 3117732 28223
SpainSite Not Available
Zai Lab Site 8003
Seville 2510911, Sevilla 41009
SpainSite Not Available
Zai Lab Site 8002
Valencia 2509954, Valencia 2593113 46009
SpainSite Not Available
Zai Lab Site 8006
Valencia 2509954, Valencia 2593113 46010
SpainSite Not Available
Zai Lab Site 8001
Barcelona, 8035
SpainSite Not Available
Zai Lab Site 8005
Barcelona, 8023
SpainActive - Recruiting
Zai Lab Site 8007
Madrid, 28040
SpainSite Not Available
Zai Lab Site 8008
Madrid, 28050
SpainActive - Recruiting
Zai Lab Site 8003
Sevilla, 41009
SpainSite Not Available
Zai Lab Site 8002
Valencia, 46009
SpainSite Not Available
Zai Lab Site 8006
Valencia, 46010
SpainActive - Recruiting
Zai Lab Site 2005
Irvine, California 92618
United StatesSite Not Available
Zai Lab Site 2005
Irvine 5359777, California 5332921 92618
United StatesSite Not Available
Zai Lab Site 2007
Detroit, Michigan 48201
United StatesSite Not Available
Zai Lab Site 2007
Detroit 4990729, Michigan 5001836 48201
United StatesSite Not Available
Zai Lab Site 2001
Hackensack, New Jersey 07601
United StatesSite Not Available
Zai Lab Site 2001
Hackensack 5098706, New Jersey 5101760 07601
United StatesSite Not Available
Zai Lab Site 2002
New York, New York 10029
United StatesSite Not Available
Zai Lab Site 2002
New York 5128581, New York 5128638 10029
United StatesSite Not Available
Zai Lab Site 2003
Spokane, Washington 99208
United StatesSite Not Available
Zai Lab Site 2003
Spokane 5811696, Washington 5815135 99208
United StatesSite Not Available

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