A Study of Sacituzumab Govitecan for Mesothelioma
This study is looking at a treatment called sacituzumab govitecan-hziy for people with mesothelioma that affects the lining of the lungs (pleural mesothelioma). You might be able to join if you are 18 or older, have been diagnosed with diffuse pleural mesothelioma, and have already received at least one other treatment like chemotherapy or immunotherapy. The main goal is to see how many people respond to the treatment over two years. The study is currently recruiting about 33 participants, but its overall status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 33 people.
- What's involved
- Participants will receive sacituzumab govitecan-hziy until their disease gets worse, they have severe side effects, or they or their doctor decide to stop treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main goal is measured at 2 years, suggesting follow-up for at least that long.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06477419
A Study of Sacituzumab Govitecan in People With Mesothelioma
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~33 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:Sacituzumab govitecan-hziy
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate
Measured over 2 years
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Michael Offin, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 months after the end of active therapy
Exclusion
Currently participating in another study and receiving another study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of the first dose of treatment
Prior hypersensitivity to irinotecan or any components of sacituzumab govitecan-hziy
Prior cytotoxic/immunologic systemic therapy within 3 weeks prior to study Day 1 or has not recovered (i.e., CTCAE v5 ≥ Grade 1 at baseline; from clinically significant adverse events due to a previously administered agent (excluding Grade 2 neuropathy)
Known psychiatric or substance abuse disorders that would interfere with the requirements of the trial within the opinion of the investigator
Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early stage prostate cancer, or in situ cervical cancer after definitive treatment
Positive hepatitis B (hepatitis B virus \[HBV\]) surface antigen (HBsAg)
Positive hepatitis C antibody (anti-HCV)
Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following:
Receiving ART that may interfere with study treatment (consult sponsor for review of medication prior to enrollment)
CD4 count \< 350 cells/mm3 at screening
AIDS-defining opportunistic infection within 6 months of start of screening
Not agreeing to start ART and be on ART \> 4 weeks plus having HIV viral load \<400 copies/mL at end of 4-week period (to ensure ART is tolerated and HIV controlled)
Myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), or coronary/peripheral artery bypass graft, or any acute coronary syndrome within 6 months of start of study drug
Congestive heart failure defined as New York Heart Association (NYHA) Class III-IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of study Day 1
Pregnant women or women who are breastfeeding or of childbearing potential and not using a highly effective method of birth control for at least one month prior to enrollment. If the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 60 days after last treatment. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent)
What this trial measures
- Overall Response Rate2 years
Clinical efficacy of SG in participants with recurrent and/or unresectable/metastatic DPM treated past the Cycle 3 tumor assessment determined by overall response rate as primarily assessed by modified (m)RECIST. Overall response rate defined as participants who achieve complete response or partial response as best overall response by modified RECIST v1.1 criteria for mesothelioma.