Actively Recruiting
Phase 2 Study of Sacituzumab Govitecan-hziy in Patients With Previously Treated Mesothelioma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-28
33
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate sacituzumab govitecan in people with mesothelioma, specifically those with diffuse pleural mesothelioma who have previously received treatment. The study is a Phase 2 clinical trial sponsored by Memorial Sloan Kettering Cancer Center, focusing on patients whose disease has not responded to earlier therapies. Participants must have measurable disease and meet other health criteria to join the study. Participants will receive sacituzumab govitecan until their disease worsens, they experience severe side effects, or the study doctor or participant decides to stop treatment. Imaging scans will be done after the first two treatment cycles and then every three cycles to monitor disease progression. Biopsies will be taken at screening, before the third treatment cycle, and optionally at the end of treatment if it is safe and agreed upon. Throughout the study, patients will be closely monitored for treatment response and side effects. Researchers will assess overall response rate over two years, including toxicity and efficacy data. Participants who leave before the third cycle assessment will be monitored for side effects only. The study includes regular scans, biopsies, and health evaluations to track progress and safety during treatment and follow-up.
CONDITIONS
Brief Title
A Study of Sacituzumab Govitecan in People With Mesothelioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or legally authorized representative willing and able to provide written informed consent
- Patient age 18 years or older at time of consent
- Pathologically confirmed diffuse pleural mesothelioma
- Must have received at least one prior systemic therapy (platinum/pemetrexed, immunotherapy, or combination)
- Measurable disease by modified RECIST criteria for mesothelioma or RECIST v1.1 at investigator discretion
- Consent to undergo biopsy prior to Cycle 1 Day 1 and Cycle 3 Day 1 if safe and feasible
- Eastern Cooperative Oncology Group (ECOG) score 0 or Karnofsky Performance Status 70% or higher
- Adequate organ function including neutrophils, platelets, renal function, hemoglobin, bilirubin, AST, and ALT
- If of childbearing potential, willingness to use highly effective contraception before, during, and after therapy
You will not qualify if you...
- Currently participating in another study with investigational therapy or used investigational agent/device within 3 weeks prior to treatment
- Prior hypersensitivity to irinotecan or sacituzumab govitecan components
- Recent cytotoxic or immunologic therapy within 3 weeks before study or unresolved significant adverse events
- Known psychiatric or substance abuse disorders interfering with trial requirements
- Additional progressing malignancy requiring active treatment (exceptions apply)
- Positive hepatitis B surface antigen or active hepatitis B or C infection without proper control
- HIV infection with interfering ART, low CD4 count, recent opportunistic infection, or uncontrolled viral load
- Recent serious cardiac events within 6 months
- Congestive heart failure NYHA Class III-IV or recent hospitalization for heart failure
- Pregnant or breastfeeding women or those not using effective contraception as required during and after study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or intolerable toxicity
Participants receive Sacituzumab govitecan-hziy until disease progression or intolerable toxicity. Imaging assessments occur after the first 2 cycles and every 3 cycles thereafter. Biopsies occur at screening, prior to cycle 3, and optionally at the end of treatment if consented and safe.
Imaging visits after 2 cycles and every 3 cycles; biopsies at screening, before cycle 3, and optional at end of treatment
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
7
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
M
Michael Offin, MD
R
Robert Daly, MD, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here