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LCB02A for Advanced Solid Tumors

This study is testing a new treatment called LCB02A for people with advanced solid tumors that have not responded to standard treatments. LCB02A is a special type of drug designed to target cancer cells that have a protein called Claudin 18.2 on their surface. The main goals of the study are to understand how safe LCB02A is, find the best dose to use, and see how well it shrinks tumors. To join, your tumor must be Claudin 18.2 positive. This study is currently in an unclear recruitment status.

Study design
This is a Phase 1/2 open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 191 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 48 months, and tumor response will be measured for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07460375

A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
LigaChem Biosciences, Inc.
~191 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:LCB02A

At a glance

Recruiting sites
1 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of LCB02A (Phase 1 and 2)
Measured over Up to 48 months
+2 more outcomes measured

Conditions

Advanced Solid Tumors

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Solid Neoplasm

NCT07460375

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • ASAN Medical Center

    Seoul, South Koreano site contact published

    Not yet recruiting

  • Mass General Hospital

    Boston, Massachusettsno site contact published

    Not yet recruiting

  • MD Anderson Cancer Center

    Houston, Texasno site contact published

    Not yet recruiting

  • Medical University of South Carolina

    Charleston, South Carolinano site contact published

    Not yet recruiting

  • Princess Margaret Hospital

    Toronto, Ontario, Canadano site contact published

    Not yet recruiting

  • Samsung Medical Center

    Seoul, South Koreano site contact published

    Not yet recruiting

  • Seoul National University Hospital

    Seoul, South Koreano site contact published

    Not yet recruiting

  • START New York - Long Island

    Lake Success, New Yorkno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Rodrigo Ruiz Soto, M.D. · STUDY_DIRECTOR · LigaChem Biosciences

Who to contact

David Browning
[email protected]
+1-615-975-7776
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Phase 1 Dose Escalation: histologically or cytologically confirmed advanced solid tumors that are Claudin 18.2 positive and refractory to standard of care treatment.
Phase 2 Dose Expansion: selected histologically or cytologically confirmed advanced solid tumors that are Claudin 18.2 positive and refractory to standard of care treatment. Expansion cohort indications will be prioritized based on data from the Phase 1 dose escalation portion.
Prior treatment with Claudin 18.2 directed therapy is permitted.
Measurable disease as defined by RECIST v1.1
Willingness to provide archival tumor tissue when available, or to undergo a pre-treatment biopsy if archival tissue is not available.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function as defined by:
Absolute neutrophil count ≥ 1.5 × 109/L , without colony stimulating factor support for the past 14 days
Platelet count ≥ 100 × 109/L
Hemoglobin level ≥ 9.0 g/dL
Total bilirubin ≤ 1.5× upper limit of normal (ULN) or \<3 x ULN with Gilbert's syndrome or liver metastases at baseline
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5× ULN (≤ 5.0× ULN for subjects with liver metastases)
Albumin ≥ 2.5 g/dL
Creatinine clearance ≥ 60 mL/min

Exclusion

Prior exposure to ADCs with a Topo1 inhibitor payload.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Received radiotherapy within 21 days prior to the first dose of study drug. Note: For palliative radiotherapy for symptomatic improvement of non-central nervous system (CNS) lesions (total duration of radiotherapy ≤ 14 days), a radiation washout period of 7 days is required prior to the first dose.
Any medical conditions that may confound the study results, interfere with the patient's compliance, or impair the interests of the subject, as assessed by the Investigator.

What this trial measures

  • Safety of LCB02A (Phase 1 and 2)Up to 48 months

    Incidence and severity of AEs

  • Recommended Phase 2 dose of LCB02A (Phase 1)Up to 24 months

    Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics

  • Objective response rate (Phase 2)Up to 24 months

    Assessed by RECIST 1.1