Clinical trial NCT05859464: A Phase 1 Study of ZL-1218 in Subjects With Advanced Solid Tumors
Official title: A Phase I, Open-label, Multicenter Study of ZL-1218 as a Single Agent and as Combination Therapy With Anti-PD-1 Antibody to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects With Advanced Solid Tumor Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Malignant Solid Tumor
Lead sponsor: Zai Lab (Hong Kong), Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Zai Biopharmaceutical (Shanghai) Co., Ltd.
name: Merck Sharp & Dohme LLC
First posted: 2023-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ZL-1218 as a single agent and as combination therapy in subjects with advanced solid tumor malignancies.


Eligibility criteria: Inclusion Criteria:

* Adult men and women ≥ 18 years of age. If 18 years is not the age of majority, then adult 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 locally advanced unresectable or metastatic advanced solid tumor that is refractory to standard treatment, or intolerant to standard treatment, or for which no standard treatment exists.Subjects must have at least one target lesion as defined by RECIST v1.1 on CT, PET/CT, or MRI scan.
* Subjects must have a site of disease which is not previously irradiated and is safe and amenable to biopsy per the treating institution's guidelines. Subjects must be willing to undergo a tumor biopsy at screening and on treatment, per the protocol guidelines.
* Subjects must have a site of disease which is not previously irradiated and is safe and amenable to biopsy per the treating institution's guidelines. Subjects must be willing to undergo a tumor biopsy at screening and on treatment, per the protocol guidelines.

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 any ingredient 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 planned start of study therapy.
* Subjects with known history of, or any evidence of active, non-infectious pneumonitis.
* 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 investigational products) within 4 weeks before first dose of study drug.
* Non-palliative radiotherapy within 2 weeks prior to first dose of study drug or have had 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 the subject's participation in the clinical study due to safety concerns, compliance with the study procedures, or interpretation of the study results.

Primary outcomes:
measure: Incidence of Dose Limiting Toxicities
timeFrame: Approximately 24 months
measure: Incidence of Treatment Emergent Adverse Events
timeFrame: Approximately 24 months
measure: Incidence of Serious adverse events
timeFrame: Approximately 24 months
measure: Clinically Significant changes in safety assessments
timeFrame: Approximately 24 months
measure: ORR per RECIST 1.1
timeFrame: up to 24 months
measure: ORR per iRECIST
timeFrame: up to 24 months
Secondary outcomes:
measure: ORR per RECIST 1.1
timeFrame: up to 24 months
measure: ORR per iRECIST
timeFrame: up to 24 months
measure: Duration of Response per RECIST 1.1
timeFrame: up to 24 months
measure: Duration of Response per iRECIST
timeFrame: up to 24 months
measure: PFS per RECIST 1.1
timeFrame: up to 24 months
measure: PFS per iRECIST
timeFrame: up to 24 months
measure: DCR per RECIST 1.1
timeFrame: up to 24 months
measure: DCR per iRECIST
timeFrame: up to 24 months
measure: Overall Survival
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): AUC
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): Cmax
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): Tmax
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): Ctrough
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): Vss
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): CL
timeFrame: up to 24 months
measure: Pharmacokinetics (PK): t1/2
timeFrame: up to 24 months
measure: Immunogenicity
timeFrame: up to 24 months
measure: Immunogenicity
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Zai Lab Site 2005
state: California
city: Detroit
country: United States
facility: Zai Lab Site 2007
state: Michigan
city: Hackensack
country: United States
facility: Zai Lab Site 2001
state: New Jersey
city: New York
country: United States
facility: Zai Lab Site 2002
state: New York
city: Spokane
country: United States
facility: Zai Lab Site 2003
state: Washington
city: Hangzhou
country: China
facility: Zai Lab Site 1002
city: Shanghai
country: China
facility: Zai Lab Site 1001
city: Pozuelo De Alarcón
country: Spain
facility: Zai Lab Site 8004
state: Madrid
city: Barcelona
country: Spain
facility: Zai Lab Site 8005
city: Barcelona
country: Spain
facility: Zai Lab Site 8001
city: Madrid
country: Spain
facility: Zai Lab Site 8007
city: Madrid
country: Spain
facility: Zai Lab Site 8008
city: Sevilla
country: Spain
facility: Zai Lab Site 8003
city: Valencia
country: Spain
facility: Zai Lab Site 8002
city: Valencia
country: Spain
facility: Zai Lab Site 8006
Study officials:
References: