Sacituzumab Govitecan for Mesothelioma

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Michael Offin

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antidepressants, Antivirals

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have received any cytotoxic or immunologic systemic therapy within 3 weeks before starting the trial treatment.

Is Sacituzumab Govitecan safe for humans?

Sacituzumab Govitecan has been studied in various cancers, and while it shows promise, it can cause side effects like low white blood cell counts (neutropenia), tiredness (fatigue), diarrhea, and low red blood cell counts (anemia). These side effects were observed in patients with small cell lung cancer and other advanced cancers. ^{1 2 3 4 5}

What makes the drug Sacituzumab Govitecan unique for treating mesothelioma?

Sacituzumab Govitecan is unique because it is an antibody-drug conjugate that specifically targets TROP-2, a protein found on many cancer cells, and delivers SN-38, a chemotherapy agent, directly to these cells. This targeted approach may offer a new treatment option for mesothelioma, which currently has limited effective therapies. ^{1 2 4 6 7}

Research Team

Michael Offin

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 18 with confirmed diffuse pleural mesothelioma who've had at least one prior systemic therapy. They must have measurable disease, good organ function, and an ECOG score of 0 or Karnofsky Performance Status ≥70%. Participants need to consent to biopsies and use effective contraception if applicable. Exclusions include recent other treatments, certain heart conditions, active infections like hepatitis B/C or HIV, other progressing cancers (with some exceptions), and pregnancy.

Inclusion Criteria

Measurable disease by modified RECIST criteria for mesothelioma

Adequate organ function: Absolute neutrophil count ≥ 1.5K/mcL, Platelet count ≥ 100K/mcL, Adequate renal function defined as creatinine clearance ≥ 30ml/min, Hemoglobin > 9g/dL, 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, AST, ALT ≤ 2.5 x ULN (if liver metastases are present, ≤5 × ULN)

I agree to have two biopsies if it's safe and possible.

Exclusion Criteria

I haven't had chemotherapy or immunotherapy in the last 3 weeks or still have side effects.

Prior hypersensitivity to irinotecan or any components of sacituzumab govitecan-hziy

Known psychiatric or substance abuse disorders that would interfere with the requirements of the trial within the opinion of the investigator

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive sacituzumab govitecan until disease progression or unacceptable toxicity

Variable (until progression or toxicity)

Cross-sectional imaging after the first 2 cycles and every 3 cycles thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Sacituzumab Govitecan (Monoclonal Antibodies)

Trial Overview The study tests Sacituzumab Govitecan in patients with mesothelioma until they experience disease progression, intolerable side effects, or decide with their doctor that it's best to stop. The drug is given repeatedly over time as long as it's safe and potentially beneficial.

Participant Groups

Group I: Participants with Mesothelioma Experimental Treatment 1 Intervention

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.

Sacituzumab Govitecan is already approved in Canada for the following indications:

Approved in Canada as Trodelvy for:

• Metastatic triple-negative breast cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Sloan Kettering Basking Ridge Basking Ridge, NJ

Memorial Sloan Kettering Cancer Center @ Commack Commack, NY

Memorial Sloan Kettering Monmouth Middletown, NJ

Memorial Sloan Kettering Bergen Montvale, NJ

More Trial Locations

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1998

Patients Recruited

602,000+

Gilead Sciences

Industry Sponsor

Trials

1150

Patients Recruited

878,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TROP2 expression and SN38 antitumor activity in malignant pleural mesothelioma cells provide a rationale for antibody-drug conjugate therapy. Hegedüs, L., Okumus, Ö., Mairinger, F., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan: First Approval. Syed, YY.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan. Gray, JE., Heist, RS., Starodub, AN., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: Safety and pharmacokinetics. Ocean, AJ., Starodub, AN., Bardia, A., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. Seligson, JM., Patron, AM., Berger, MJ., et al.[2021]

Sacituzumab govitecan (IMMU-132) is an antibody-drug conjugate that effectively targets Trop-2, showing significant antitumor effects in various solid tumors, including gastric and pancreatic cancers, in mouse models.

The drug demonstrated a favorable pharmacokinetic profile with a mean residence time of 15.4 hours, and ongoing clinical trials are confirming its anticancer activity in patients with Trop-2 expressing tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2/SN-38 Antibody-Drug Conjugate: Characterization and Efficacy in Pancreatic, Gastric, and Other Cancers. Cardillo, TM., Govindan, SV., Sharkey, RM., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. Starodub, AN., Ocean, AJ., Shah, MA., et al.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

TROP2 expression and SN38 antitumor activity in malignant pleural mesothelioma cells provide a rationale for antibody-drug conjugate therapy. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan: First Approval. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: Safety and pharmacokinetics. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2/SN-38 Antibody-Drug Conjugate: Characterization and Efficacy in Pancreatic, Gastric, and Other Cancers. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. [2022]