A Study of Sacituzumab Govitecan in People With Mesothelioma (NCT06477419) | Clinical Trial Compass
RecruitingPhase 2
A Study of Sacituzumab Govitecan in People With Mesothelioma
United States33 participantsStarted 2024-06-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 bilirubin ≤1.5 x upper limit of normal (ULN) if no liver metastases or \<3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits
* AST, ALT ≤ 2.5 x ULN (if liver metastases are present, ≤5 × ULN)
* If of childbearing potential, must be willing to use highly effective mode of contraception for at least one month prior, during, and for 2 …