Testing ZL-1218 for advanced solid tumors

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

This study is testing a new treatment called ZL-1218, alone and with another drug, to see if it can help adults with advanced solid tumors that haven't responded to other therapies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zai Lab (Hong Kong), Ltd. (industry)
• Drugs / interventions: radiation
• Locations: 15 sites (Irvine, California and 14 other locations)
• Trial ID: NCT05859464 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ZL-1218, both as a standalone treatment and in combination with Pembrolizumab, in patients with advanced solid tumors. Participants will be adults with confirmed diagnoses of locally advanced unresectable or metastatic solid tumors that have not responded to standard treatments. The study will involve tumor biopsies to assess treatment effects and will follow a structured protocol to monitor patient responses.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors that are refractory to standard treatments.

Not a fit: Patients with solid tumors that are amenable to standard treatment or those with a life expectancy of less than 12 weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are resistant to existing therapies.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific combination of ZL-1218 and Pembrolizumab is novel.

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.

Where this trial is running

Irvine, California and 14 other locations

• Zai Lab Site 2005 — Irvine, California, United States (RECRUITING)
• Zai Lab Site 2007 — Detroit, Michigan, United States (RECRUITING)
• Zai Lab Site 2001 — Hackensack, New Jersey, United States (RECRUITING)
• Zai Lab Site 2002 — New York, New York, United States (RECRUITING)
• Zai Lab Site 2003 — Spokane, Washington, United States (RECRUITING)
• Zai Lab Site 1002 — Hangzhou, China (RECRUITING)
• Zai Lab Site 1001 — Shanghai, China (RECRUITING)
• Zai Lab Site 8004 — Pozuelo De Alarcón, Madrid, Spain (RECRUITING)
• Zai Lab Site 8005 — Barcelona, Spain (RECRUITING)
• Zai Lab Site 8001 — Barcelona, Spain (RECRUITING)
• Zai Lab Site 8007 — Madrid, Spain (RECRUITING)
• Zai Lab Site 8008 — Madrid, Spain (RECRUITING)
• Zai Lab Site 8003 — Sevilla, Spain (RECRUITING)
• Zai Lab Site 8002 — Valencia, Spain (RECRUITING)
• Zai Lab Site 8006 — Valencia, Spain (RECRUITING)

Study contacts

• Study coordinator: Zai Lab 1218-001 Study Team

Conditions: Malignant Solid Tumor