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Malignant Solid TumorPhase 1NCT05859464

A Phase 1 Study of ZL-1218 in Subjects With Advanced Solid Tumors

A Phase 1 study testing ZL-1218 and Pembrolizumab in people with Malignant Solid Tumor, run by Zai Lab (Hong Kong), Ltd. at 15 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Solid Tumor
What is being tested?
ZL-1218 and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
15 sitesin 3 countries
Study dates
24 Jul 2023to 28 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

15 sites in 3 countries.

15 sites in 3 countries

Spain8 sites

  • Zai Lab Site 8005

    Barcelona, Barcelona, 8023

  • Zai Lab Site 8001

    Barcelona, Barcelona, 8035

  • Zai Lab Site 8007

    Madrid, Madrid, 28040

  • Zai Lab Site 8008

    Madrid, Madrid, 28050

  • Zai Lab Site 8004

    Pozuelo de Alarcón, Madrid, 28223

  • Zai Lab Site 8003

    Seville, Sevilla, 41009

  • Zai Lab Site 8002

    Valencia, Valencia, 46009

  • Zai Lab Site 8006

    Valencia, Valencia, 46010

Other trials in Spain

United States5 sites

  • Zai Lab Site 2007

    Detroit, Michigan, 48201

  • Zai Lab Site 2001

    Hackensack, New Jersey, 07601

  • Zai Lab Site 2005

    Irvine, California, 92618

  • Zai Lab Site 2002

    New York, New York, 10029

  • Zai Lab Site 2003

    Spokane, Washington, 99208

Other trials in United States

China2 sites

  • Zai Lab Site 1002

    Hangzhou, 310009

  • Zai Lab Site 1001

    Shanghai, 200123

Other trials in China

About this study

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

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.

Being tested
ZL-1218, Pembrolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZL-1218Drug

    ZL-1218 dose escalation

  • PembrolizumabDrug

    Combination treatment with ZL-1218

Study groups in NCT05859464
Study groupRoleWhat they receive
Part 1: Dose Escalation; ZL-1218ExperimentalDrug: ZL-1218 ZL-1218 dose escalation
Receives: Drug: ZL-1218
Part 1: Dose Escalation; ZL-1218 in combination with PembrolizumabExperimentalDrug: ZL-1218 ZL-1218 dose escalation Drug: Pembrolizumab (KEYTRUDA®) Combination treatment with ZL-1218
Receives: Drug: ZL-1218; Drug: Pembrolizumab
Part 2: Cohort Expansion; Prior CPI TherapyExperimentalDrug: ZL-1218 ZL-1218 recommended dose Drug: Pembrolizumab (KEYTRUDA®) Combination treatment with ZL-1218
Receives: Drug: ZL-1218; Drug: Pembrolizumab
Part 2: Cohort Expansion; CPI therapy NaiveExperimentalDrug: ZL-1218 ZL-1218 recommended dose Drug: Pembrolizumab (KEYTRUDA®) Combination treatment with ZL-1218
Receives: Drug: ZL-1218; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose Limiting Toxicities

    Number of subjects with dose limiting toxicities (DLTs) through dose escalation only.

    Measured: Approximately 24 months

  2. Incidence of Treatment Emergent Adverse Events

    Number of subjects with treatment-emergent adverse effects through dose escalation and expansion.

    Measured: Approximately 24 months

  3. Incidence of Serious adverse events

    Number of subjects with Serious Adverse Events through dose escalation and expansion.

    Measured: Approximately 24 months

  4. Clinically Significant changes in safety assessments

    Changes in safety assessment parameters (e.g., vital signs, electrocardiograms [ECGs], and clinical laboratory results) through dose escalation and expansion.

    Measured: Approximately 24 months

  5. ORR per RECIST 1.1

    Objective Response Rate (ORR) per RECIST 1.1 through dose expansion only.

    Measured: up to 24 months

  6. ORR per iRECIST

    Objective Response Rate per iRECIST through dose expansion only.

    Measured: up to 24 months

Secondary outcomes (18)

  1. ORR per RECIST 1.1

    Objective Response Rate (ORR) per RECIST 1.1 through dose escalation only.

    Measured: up to 24 months

  2. ORR per iRECIST

    Objective Response Rate (ORR) per iRECIST through dose escalation only.

    Measured: up to 24 months

  3. Duration of Response per RECIST 1.1

    Duration of Response per RECIST 1.1 through dose escalation and expansion.

    Measured: up to 24 months

  4. Duration of Response per iRECIST

    Duration of Response per iRECIST through dose escalation and expansion.

    Measured: up to 24 months

  5. PFS per RECIST 1.1

    Progression-Free Survival (PFS) per RECIST 1.1 through dose escalation and expansion.

    Measured: up to 24 months

  6. PFS per iRECIST

    Progression-Free Survival (PFS) per iRECIST through dose escalation and expansion.

    Measured: up to 24 months

  7. DCR per RECIST 1.1

    Disease Control Rate (DCR) per RECIST 1.1 through dose escalation and expansion.

    Measured: up to 24 months

  8. DCR per iRECIST

    Disease Control Rate (DCR) per iRECIST through dose escalation and expansion.

    Measured: up to 24 months

  9. Overall Survival

    Overall Survival (OS) through dose escalation and expansion.

    Measured: up to 24 months

  10. Pharmacokinetics (PK): AUC

    Area under curve (AUC) through dose escalation and expansion.

    Measured: up to 24 months

  11. Pharmacokinetics (PK): Cmax

    Maximum serum concentration (CMax) through dose escalation and expansion.

    Measured: up to 24 months

  12. Pharmacokinetics (PK): Tmax

    Time to reach Cmax (Tmax) through dose escalation and expansion.

    Measured: up to 24 months

  13. Pharmacokinetics (PK): Ctrough

    Ctrough through dose escalation and expansion.

    Measured: up to 24 months

  14. Pharmacokinetics (PK): Vss

    Volume of distribution as steady state (Vss) through dose escalation and expansion.

    Measured: up to 24 months

  15. Pharmacokinetics (PK): CL

    Clearance (CL) through dose escalation and expansion.

    Measured: up to 24 months

  16. Pharmacokinetics (PK): t1/2

    Half-life (t1/2) through dose escalation and expansion.

    Measured: up to 24 months

  17. Immunogenicity

    Incidence of anti-drug antibodies (ADAs) through dose escalation and expansion.

    Measured: up to 24 months

  18. Immunogenicity

    Quantity of anti-drug antibodies (ADAs) through dose escalation and expansion.

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2023
  2. Study start24 Jul 2023
  3. Primary completion28 Aug 2025
  4. Study completion28 Aug 2025

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05859464
Sponsor's protocol ID
ZL-1218-001
Other IDs
KEYNOTE-F22, MK-3475-F22
Status last verified
Jan 2025
First submitted
17 Mar 2023
Last updated
20 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZL-1218 and Pembrolizumab in people with Malignant Solid Tumor, run by Zai Lab (Hong Kong), Ltd. at 15 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain, United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limiting Toxicities (time frame: Approximately 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05859464.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.

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