A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors (NCT07460375) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors
United States, Canada, South Korea191 participantsStarted 2026-08
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Serum creatinine ≤ 1.5× ULN or creatinine clearance ≥ 50 mL/min
Key Exclusion Criteria:
* Prior exposure to ADCs with a Topo1 inhibitor payload.
* Known active central nervous system (CNS) metastases and/o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.