A Study of Sacituzumab Govitecan in People With Mesothelioma

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.

Study Overview

• Status: Recruiting
• Conditions: Mesothelioma; Mesotheliomas Pleural; Mesothelioma; Pleura
• Intervention / Treatment: Drug: Sacituzumab govitecan-hziy

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Michael Offin, MD; Phone Number: 646-608-3763; Email: offinm@mskcc.org
• Study Contact Backup: Name: Robert Daly, MD, MBA; Phone Number: 646-608-3789; Email: dalyr1@mskcc.org

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge
      • Contact: Michael Offin, MD; Phone Number: 646-449-1778
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth
      • Contact: Michael Offin, MD; Phone Number: 646-608-3763
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen
      • Contact: Michael Offin, MD; Phone Number: 646-608-3763
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Cancer Center @ Commack
      • Contact: Michael Offin, MD; Phone Number: 646-608-3763
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester
      • Contact: Michael Offin, MD; Phone Number: 646-608-3763
    • New York, New York, United States, 10021
      • Recruiting
      • Memorial Sloan - Kettering Cancer Center
      • Contact: Michael Offin, MD; Phone Number: 646-608-3763
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau
      • Contact: Michael Offin, MD; Phone Number: 646-608-3763

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 months after the end of active therapy

Exclusion Criteria:

• 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)

  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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participants with Mesothelioma; Participants 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.

Drug: Sacituzumab govitecan-hziy; After enrollment, participants will receive SG until disease progression or intolerable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Michael Offin, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2024
• Primary Completion (Estimated): June 21, 2029
• Study Completion (Estimated): June 21, 2029

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; Mesothelioma; Sacituzumab; Mesotheliomas Pleural; Mesothelioma; Pleura; Diffuse Pleural Mesothelioma; 24-081
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Mesothelioma, Malignant; Mesothelioma; Immunologic Factors; Physiological Effects of Drugs; Immunoconjugates; Sacituzumab govitecan
• Other Study ID Numbers: 24-081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No