A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LCB02A.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A First-in-Human Phase 1/2, Dose Escalation and Dose Expansion Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of Claudin18.2 (CLDN18.2)-Directed Antibody-Drug Conjugate (ADC) LCB02A in Patients With CLDN18.2-positive Advanced Solid Tumors
Overview
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]
- Recommended Phase 2 dose of LCB02A (Phase 1) [Time frame: Up to 24 months]
- Objective response rate (Phase 2) [Time frame: Up to 24 months]
Secondary outcome measures (5)
- Plasma concentrations of LCB02A (Phase 1 and 2) [Time frame: Up to 48 months]
- Duration of Response (Phase 1 and 2) [Time frame: Up to 48 months]
- Disease control rate (Phase 1 and Phase 2) [Time frame: Up to 48 months]
- Progression Free Survival (Phase 1 and Phase 2) [Time frame: Up to 48 months]
- Overall Survival (Phase 1 and Phase 2) [Time frame: Up to 48 months]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Mass General Hospital — Boston
- START New York - Long Island — Lake Success
- Medical University of South Carolina — Charleston
- MD Anderson Cancer Center — Houston
South Korea · 3 centers
- Seoul National University Hospital — Seoul
- ASAN Medical Center — Seoul
- Samsung Medical Center — Seoul
Canada · 1 center
- Princess Margaret Hospital — Toronto
Identifiers
NCT: NCT07460375 · LCB02A-1001