A Study of Sacituzumab Govitecan in People With Mesothelioma
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Participants will receive sacituzumab govitecan until their disease gets worse (progresses), they have severe side effects and cannot continue study treatment, or the participants or the study doctor thinks it's in your best interest to stop treatment.
Eligibility Criteria
Inclusion Criteria: * Patient, or legally authorized representative (LAR), willing and able to provide written informed consent for the trial * Patient age ≥ 18 at time of consent * Pathologically confirmed diffuse pleural mesothelioma * Must have received at least one prior systemic therapy (platinum/pemetrexed, immunotherapy or a combination thereof) * Measurable disease as defined primarily by the modified RECIST criteria for mesothelioma (at PI discretion RECIST v1.1 may be used) * Consent to undergo a biopsy prior to Cycle 1 Day 1 and Cycle 3 Day 1 if deemed medically safe and feasible * Eastern Cooperative Oncology Group (ECOG) score 0 or Karnofsky Performance Status ≥ 70% * Adequate organ function, defined as * Absolute neutrophil count ≥ 1.5K/mcL * Platelet count ≥ 100K/mcL * Adequate renal function defined as creatinine clearance ≥ 30ml/min (as calculated by Cockcroft-Gault Formula) * Hemoglobin \> 9g/dL (prior transfusion permitted if not within 7 days of enrollment) * Total