Sacituzumab Govitecan for Glioblastoma

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by William Kelly, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Bevacizumab, Warfarin, Enzyme-inducing antiepileptics

Disqualifiers: Hypertension, Cardiac arrhythmias, Infection, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment or drug on all patients in the study to see if it is effective and safe.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot take certain medications like enzyme-inducing anti-epileptic drugs within 14 days of the study drug. If you're on warfarin, you need to switch to low molecular weight heparin before starting the trial.

What data supports the effectiveness of the drug Sacituzumab Govitecan for treating glioblastoma?

Sacituzumab Govitecan has shown promise in treating various cancers, such as triple-negative breast cancer and malignant pleural mesothelioma, by targeting a protein called Trop-2 on cancer cells and delivering a powerful cancer-fighting agent, SN-38, directly to them. While specific data for glioblastoma is not available, its success in other cancers suggests potential effectiveness. ^{1 2 3 4 5}

What is known about the safety of Sacituzumab Govitecan in humans?

Sacituzumab Govitecan has been studied for safety in treating various cancers, with common side effects including neutropenia (low white blood cell count), diarrhea, colitis (inflammation of the colon), and sepsis (a severe infection). Most adverse events occur within 30 days of starting treatment, and certain conditions like colitis and sepsis can lead to hospitalization, especially in males. ^{1 3 6 7 8}

How is the drug Sacituzumab Govitecan unique for treating glioblastoma?

Sacituzumab Govitecan is unique because it is an antibody-drug conjugate that specifically targets a protein called Trop-2 on cancer cells, delivering a powerful chemotherapy agent, SN-38, directly to the tumor, which may enhance its effectiveness compared to standard treatments. ^{1 2 3 4 9}

Research Team

William Kelly, MD

Principal Investigator

Mays Cancer Center, UT Health San Antonio

Eligibility Criteria

Adults with confirmed IDH wild-type glioblastoma that has progressed after standard treatment, including radiation and chemotherapy. Participants must have stable vital signs, acceptable blood counts, liver and kidney function, agree to use contraception, and not be pregnant or breastfeeding. They should not have had certain recent treatments or surgeries and must be willing to stop using tumor treatment field therapy.

Inclusion Criteria

I have recovered from previous treatment side effects, except for mild neuropathy or hair loss.

My biological samples are available for further testing.

I understand the study's risks and have signed the consent form.

Exclusion Criteria

I have a serious health condition like uncontrolled high blood pressure or heart issues.

I am taking warfarin or similar drugs and cannot switch to LMWH before starting the study drug.

The subject is unable to undergo MRI scan (eg, has pacemaker).

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Sacituzumab Govitecan at 10 mg/kg on days 1 and 8 of a 21-day cycle

6 months

2 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sacituzumab Govitecan (Monoclonal Antibodies)

Trial Overview The trial is testing Sacituzumab Govitecan as a single agent in an open-label setting for recurrent glioblastoma patients. Everyone in the study will receive this investigational drug to evaluate its effectiveness against this type of brain cancer.

Participant Groups

Group I: Sacituzumab govitecan Experimental Treatment 1 Intervention

Dosing will be at 10 mg/kg on days 1 and 8 of a 21-day cycle

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

Approved in Canada as Trodelvy for:

• Metastatic triple-negative breast cancer

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Dr. Andrew Masica

The University of Texas Health Science Center at San Antonio

Chief Medical Officer

MD from Indiana University School of Medicine

Dr. Taylor Eighmy

The University of Texas Health Science Center at San Antonio

Acting President

PhD in Civil Engineering from the University of New Hampshire

Findings from Research

Sacituzumab govitecan (SG) demonstrated effectiveness in treating relapsed or refractory metastatic triple-negative breast cancer (RM-TNBC), with a median overall survival of 12.9 months and an objective response rate of 34% based on an analysis of 412 patients across three trials.

The treatment was associated with significant adverse effects, particularly myelosuppression, with 46% of patients experiencing grade ≥3 neutropenia, and there were four treatment-related deaths reported, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated analysis of Sacituzumab govitecan in relapsed or refractory metastatic triple-negative breast cancer. Cheng, SX., Chen, QC., Lin, GH., et al.[2023]

Sacituzumab govitecan (SG) is an FDA-approved antibody-drug conjugate that has shown significant efficacy in treating metastatic triple-negative breast cancer, improving health-related quality of life and prolonging progression-free and overall survival in patients who have undergone multiple prior therapies.

Ongoing clinical trials are exploring the potential of SG for broader applications, including neoadjuvant and adjuvant therapies, combinations with immunotherapy, and treatment of various solid tumors, indicating its promise as a versatile cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of sacituzumab govitecan in solid tumors. Veeraballi, S., Khawar, Z., Aslam, HM., et al.[2023]

A study analyzing 1072 cases from the FDA Adverse Event Reporting System identified significant safety concerns with Sacituzumab Govitecan, particularly related to blood and lymphatic system disorders, gastrointestinal issues, and severe infections like neutropenic sepsis and colitis.

Unexpected serious safety signals were also noted, including large intestine perforation and hepatic failure, with geriatric patients being at a notably higher risk for several adverse events, highlighting the need for careful monitoring and management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing real-world safety concerns of Sacituzumab govitecan: a disproportionality analysis using spontaneous reports in the FDA adverse event reporting system. Gui, X., Zhao, J., Ding, L., et al.[2023]

References

1. 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]

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

An integrated analysis of Sacituzumab govitecan in relapsed or refractory metastatic triple-negative breast cancer. [2023]

3. 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]

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

Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. [2019]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Role of sacituzumab govitecan in solid tumors. [2023]

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

Postmarketing safety of Sacituzumab govitecan: a pharmacovigilance study based on FDA adverse event reporting system (FAERS). [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Assessing real-world safety concerns of Sacituzumab govitecan: a disproportionality analysis using spontaneous reports in the FDA adverse event reporting system. [2023]

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

Sacituzumab Govitecan: First Approval. [2021]