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New treatment option for Mesothelioma
Official title A Study of Sacituzumab Govitecan in People With Mesothelioma
ClinicalTrials.gov ID: NCT06477419
What this study is testing
What is Sacituzumab govitecan-hziy?
Sacituzumab govitecan-hziy is an investigational medicine, being studied as a potential treatment for mesothelioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- Currently participating in another study and receiving another study therapy or has participated in a study of an investigational agent and received...
- 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...
- 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...
- Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) o NOTE: people with a prior history of HBV demonstrated by positive hepatitis...
See the full eligibility 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; people with Gilbert's...
- 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
- 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...
- 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...
- 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...
- Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) o NOTE: people with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative...
- Positive hepatitis C antibody (anti-HCV) o NOTE: people with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.