Trial Title:
A Phase 1 Study of ZL-1218 in Subjects With Advanced Solid Tumors
NCT ID:
NCT05859464
Condition:
Malignant Solid Tumor
Conditions: Official terms:
Neoplasms
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ZL-1218
Description:
ZL-1218 dose escalation
Arm group label:
Part 1: Dose Escalation; ZL-1218
Arm group label:
Part 1: Dose Escalation; ZL-1218 in combination with Pembrolizumab
Arm group label:
Part 2: Cohort Expansion; CPI therapy Naive
Arm group label:
Part 2: Cohort Expansion; Prior CPI Therapy
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Combination treatment with ZL-1218
Arm group label:
Part 1: Dose Escalation; ZL-1218 in combination with Pembrolizumab
Arm group label:
Part 2: Cohort Expansion; CPI therapy Naive
Arm group label:
Part 2: Cohort Expansion; Prior CPI Therapy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zai Lab Site 2005
Address:
City:
Irvine
Zip:
92618
Country:
United States
Facility:
Name:
Zai Lab Site 2007
Address:
City:
Detroit
Zip:
48201
Country:
United States
Facility:
Name:
Zai Lab Site 2001
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Facility:
Name:
Zai Lab Site 2002
Address:
City:
New York
Zip:
10029
Country:
United States
Facility:
Name:
Zai Lab Site 2003
Address:
City:
Spokane
Zip:
99208
Country:
United States
Facility:
Name:
Zai Lab Site 1002
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Facility:
Name:
Zai Lab Site 1001
Address:
City:
Shanghai
Zip:
200123
Country:
China
Facility:
Name:
Zai Lab Site 8004
Address:
City:
Pozuelo De Alarcón
Zip:
28223
Country:
Spain
Facility:
Name:
Zai Lab Site 8005
Address:
City:
Barcelona
Zip:
8023
Country:
Spain
Facility:
Name:
Zai Lab Site 8001
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Facility:
Name:
Zai Lab Site 8007
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Facility:
Name:
Zai Lab Site 8008
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Facility:
Name:
Zai Lab Site 8003
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Facility:
Name:
Zai Lab Site 8002
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Facility:
Name:
Zai Lab Site 8006
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Start date:
July 24, 2023
Completion date:
November 2025
Lead sponsor:
Agency:
Zai Lab (Hong Kong), Ltd.
Agency class:
Industry
Collaborator:
Agency:
Zai Biopharmaceutical (Shanghai) Co., Ltd.
Agency class:
Other
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Zai Lab (Hong Kong), Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05859464
