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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllLigaChem Biosciences, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 1.5 ร— 109/L , without colony stimulating factor support for the past 14 days * Platelet count โ‰ฅ 100 ร— 109/L * Hemoglobin level โ‰ฅ 9.0 g/dL * Total bilirubin โ‰ค 1.5ร— upper limit of normal (ULN) or \<3 x ULN with Gilbert's syndrome or liver metastases at baseline * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) โ‰ค 2.5ร— ULN (โ‰ค 5.0ร— ULN for subjects with liver metastases) * Albumin โ‰ฅ 2.5 g/dL * Creatinine clearance โ‰ฅ 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 โ‰ค 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.
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What it tests

  • LCB02A
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Where

8 sites
Mass General Hospital
Boston, United States
START New York - Long Island
Lake Success, United States
Medical University of South Carolina
Charleston, United States
MD Anderson Cancer Center
Houston, United States
Princess Margaret Hospital
Toronto, Canada
Seoul National University Hospital
Seoul, South Korea
ASAN Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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