AzTrials
AzTrials

MesotheliomaPhase 2NCT06477419

A Study of Sacituzumab Govitecan in People With Mesothelioma

A Phase 2 study testing Sacituzumab govitecan-hziy in people with Mesothelioma and Mesotheliomas Pleural, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacituzumab govitecan-hziy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
7 sitesUnited States
Study dates
21 Jun 2024to 21 Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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)
Show all 17Show fewer
  • o NOTE: Subjects with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Patients who fit these criteria must use Hep B prophylaxis during treatment. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing
  • Positive hepatitis C antibody (anti-HCV)
  • o NOTE: Subjects 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 testing are eligible
  • 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)

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Michael Offin, MD contact

646-608-3763

offinm@mskcc.org

Robert Daly, MD, MBA contact

646-608-3789

dalyr1@mskcc.org

7 sites in 1 country

United States7 sites, 7 recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Michael Offin, MD, 646-449-1778

    Recruiting

  • Memorial Sloan Kettering Cancer Center @ Commack

    Commack, New York, 11725

    Michael Offin, MD, 646-608-3763

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Michael Offin, MD, 646-608-3763

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Michael Offin, MD, 646-608-3763

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Michael Offin, MD, 646-608-3763

    Recruiting

  • Memorial Sloan - Kettering Cancer Center

    New York, New York, 10021

    Michael Offin, MD, 646-608-3763

    Recruiting

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

    Michael Offin, MD, 646-608-3763

    Recruiting

Other trials in United States

About this study

Official title: Phase 2 Study of Sacituzumab Govitecan-hziy in Patients With Previously Treated Mesothelioma

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.

Being tested
Sacituzumab govitecan-hziy
Keywords
Mesothelioma, Mesotheliomas Pleural, Mesothelioma; Pleura, Diffuse Pleural Mesothelioma, Sacituzumab, 24-081, Memorial Sloan Kettering Cancer Center
Medical subject headings
Mesothelioma, Mesothelioma, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab govitecan-hziyDrug

    After enrollment, participants will receive SG until disease progression or intolerable toxicity.

Study groups in NCT06477419
Study groupRoleWhat they receive
Participants with MesotheliomaExperimentalParticipants will have pathologically confirmed diffuse pleural mesothelioma. Patients will undergo cross-sectional imaging after the first 2 cycles and subsequently after every 3 cycles until disease progression. Biopsies will take place at screening, prior to cycle 3, and an optional biopsy at the end of treatment if consent was obtained and deemed to be safe and feasible. Patients treated on study who are removed prior to the Cycle 3 tumor assessment will be evaluated for toxicity only and replaced. All patients treated past the Cycle 3 tumor assessment will be include in the toxicity and efficacy assessments.
Receives: Drug: Sacituzumab govitecan-hziy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2024
  2. Study start21 Jun 2024
  3. Primary completion21 Jun 2029 (estimated)
  4. Study completion21 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06477419
Sponsor's protocol ID
24-081
Status last verified
May 2026
First submitted
21 Jun 2024
Last updated
28 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab govitecan-hziy in people with Mesothelioma and Mesotheliomas Pleural, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael Offin, MD (646-608-3763, offinm@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06477419.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in