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New drug combo tested for tough cancers

NCT ID NCT05859464

Disease control Sponsor: Zai Lab (Hong Kong), Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new drug called ZL-1218, alone or with another cancer drug, in 34 adults with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety, side effects, and how the drug moves through the body. The study was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

34 people

The number who actually took part.

Started

Jul 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignant solid tumor

Contacts and locations

Locations

  • Zai Lab Site 1001

    Shanghai, 200123, China

  • Zai Lab Site 1002

    Hangzhou, 310009, China

  • Zai Lab Site 2001

    Hackensack, New Jersey, 07601, United States

  • Zai Lab Site 2002

    New York, New York, 10029, United States

  • Zai Lab Site 2003

    Spokane, Washington, 99208, United States

  • Zai Lab Site 2005

    Irvine, California, 92618, United States

  • Zai Lab Site 2007

    Detroit, Michigan, 48201, United States

  • Zai Lab Site 8001

    Barcelona, Barcelona, 8035, Spain

  • Zai Lab Site 8002

    Valencia, Valencia, 46009, Spain

  • Zai Lab Site 8003

    Seville, Sevilla, 41009, Spain

  • Zai Lab Site 8004

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Zai Lab Site 8005

    Barcelona, Barcelona, 8023, Spain

  • Zai Lab Site 8006

    Valencia, Valencia, 46010, Spain

  • Zai Lab Site 8007

    Madrid, Madrid, 28040, Spain

  • Zai Lab Site 8008

    Madrid, Madrid, 28050, Spain

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