NCT07460375 · LigaChem Biosciences, Inc.
A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors
What this study is about
This is a Phase 1/2 open label study consisting of gradually increasing doses cohorts (Phase 1) followed by expansion cohorts (Phase 2). The Phase 1 gradually increasing doses population includes subjects with advanced solid tumors that are refractory to the usual treatment therapy or for whom no the usual treatment options are available.
View original scientific description
This is a Phase 1/2 open label study consisting of dose escalation cohorts (Phase 1) followed by expansion cohorts (Phase 2). The Phase 1 dose escalation population includes subjects with advanced solid tumors that are refractory to standard of care therapy or for whom no standard of care options are available. Once the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of single agent LCB02A is determined, the study will proceed to Phase 2 expansion cohorts in selected tumor types.
Interventions
DRUG
LCB02A
CLDN18.2-directed human monoclonal antibody (Ab) linked to a topoisomerase I inhibiting payload.
Primary outcome measures
Safety of LCB02A (Phase 1 and 2)
Time frame: Up to 48 months
Incidence and severity of AEs
Recommended Phase 2 dose of LCB02A (Phase 1)
Time frame: Up to 24 months
Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics
Objective response rate (Phase 2)
Time frame: Up to 24 months
Assessed by RECIST 1.1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 Key
Exclusion criteria
- Prior exposure to ADCs with a Topo1 inhibitor payload.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients may be considered for enrollment if they have previously treated brain metastases that are clinically stable or radiologically stable for at least 14 days prior to the first dose.
- 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.
Where
- Boston, Massachusetts
- Lake Success, New York
- Charleston, South Carolina
- Houston, Texas
Collaborators
AntibodyChem Biosciences, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2026 · Source of record for eligibility and locations