Claudin 18.2-targeted therapy LCB02A in advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a combined Phase 1/2, open-label trial of LCB02A given in dose-escalation cohorts to determine safety and recommended dosing, followed by expansion cohorts in selected Claudin 18.2–positive tumors. Participants in Phase 1 must have advanced solid tumors refractory to standard therapy, with measurable disease and good performance status. After identifying the maximum tolerated or recommended Phase 2 dose, the study moves to Phase 2 expansion cohorts to further evaluate activity in prioritized tumor types. Prior Claudin 18.2–directed treatment is allowed, and tissue samples may be required for enrollment and correlative analyses.

Why it matters

Who can join: the full rules

Key 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 it's running

• START New York - Long Island
  Lake Success, New York, United States Recruiting
• Princess Margaret Hospital
  Toronto, Ontario, Canada Recruiting
• Mass General Hospital
  Boston, Massachusetts, United States Not yet recruiting
• Medical University of South Carolina
  Charleston, South Carolina, United States Not yet recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Not yet recruiting
• Seoul National University Hospital
  Seoul, South Korea Not yet recruiting

Study contacts

• Study coordinator: David Browning
• Email: clinicaltrials@ligachembio.com
• Phone: +1-615-975-7776

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.