Sacituzumab Govitecan for Cervical Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Alessandro Santin

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Yale University

Must not be taking: UGT1A1 inhibitors

Disqualifiers: Pregnancy, Cardiac disease, CNS metastases, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132) in subjects with recurrent or persistent cervical cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you must be at least 2 weeks beyond prior treatments like chemotherapy, investigational drugs, or high-dose corticosteroids, and a 4-week washout period is required after prior immunotherapy.

Is Sacituzumab Govitecan safe for humans?

Sacituzumab Govitecan has been shown to have a well-defined and manageable safety profile in patients with various cancers, including breast cancer. While there is limited information on managing side effects, early and proactive management can help maintain patient quality of life during treatment. ^{1 2 3 4 5}

What makes the drug Sacituzumab Govitecan unique for treating cervical cancer?

Sacituzumab Govitecan is unique because it is an antibody-drug conjugate that targets Trop-2, a protein found on many cancer cells, and delivers SN-38, a powerful cancer-fighting agent. This targeted approach is different from traditional chemotherapy, which affects both cancerous and healthy cells. ^{1 2 3 4 6}

Eligibility Criteria

This trial is for adults with recurrent or persistent cervical cancer who have had at least one chemotherapy regimen. They must not be pregnant, breastfeeding, or have other invasive cancers in the last 5 years. Participants need functioning major organs and controlled health conditions without significant heart disease, infections, or uncontrolled hypertension.

Inclusion Criteria

I am 18 years old or older.

I have had at most 2 chemotherapy treatments for my cervical cancer.

I can provide a sample of my tumor for testing.

Exclusion Criteria

Patients with Gilbert's disease

I have not had an intestinal blockage in the last 6 months.

I have been treated with topoisomerase I inhibitors before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sacituzumab govitecan, 10 mg/kg for the first 2 weeks of a 21-day cycle until progression or adverse effects prohibit further treatment

Until progression or adverse effects

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 years

Treatment Details

Interventions

• Sacituzumab Govitecan (Monoclonal Antibodies)

Trial Overview The study tests Sacituzumab Govitecan (IMMU-132) on patients with cervical cancer that has come back or hasn't gone away after treatment. It's a Phase 2 trial where all participants receive the drug; there's no comparison group.

Participant Groups

Group I: Sacituzumab Govitecan Experimental Treatment 1 Intervention

Sacituzumab govitecan, 10 mg/kg for the first 2 weeks of 21-day cycle until progression or adverse effects prohibit further treatment.

Sacituzumab Govitecan is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Trodelvy for:

• Metastatic triple-negative breast cancer
• Locally advanced or metastatic urothelial cancer (withdrawn)
• Metastatic HR+/HER2- breast cancer

🇪🇺 Approved in European Union as Trodelvy for:

• Metastatic triple-negative breast cancer

🇨🇦 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:

Smilow Cancer Hospital at Yale New Haven New Haven, CT

Who Is Running the Clinical Trial?

Yale University Lead Sponsor

Alessandro Santin Lead Sponsor

Gilead Sciences Industry Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan for Metastatic Triple-Negative Breast Cancer: Clinical Overview and Management of Potential Toxicities. [2021] Patients with metastatic triple-negative breast cancer have a poor prognosis. Sacituzumab govitecan (IMMU-132) is an antibody-drug conjugate that contains the irinotecan active metabolite, SN-38, linked to a humanized monoclonal antibody targeting trophoblast cell surface antigen 2, which is overexpressed in many solid tumors. In a basket design phase I/II study, sacituzumab govitecan demonstrated promising single-agent therapeutic activity in multiple cancer cohorts, leading to accelerated approval by the U.S. Food and Drug Administration of sacituzumab govitecan-hziy (TRODELVY) for the treatment of patients with metastatic triple-negative breast cancer who had received at least two prior therapies in the metastatic setting. Recently, results of the phase III trial, ASCENT, were confirmatory. There is limited available information on the adverse event management with sacituzumab govitecan needed to maximize the dose and duration of effective therapy while maintaining patient quality of life. This review summarizes the clinical development and the practical management of patients receiving sacituzumab govitecan. Sacituzumab govitecan has a well-defined and manageable toxicity profile, and rapid recognition and appropriate early and proactive management will allow clinicians to optimize sacituzumab govitecan treatment for patients. IMPLICATIONS FOR PRACTICE: Sacituzumab govitecan (TRODELVY) is a novel antibody-drug conjugate composed of the active metabolite of irinotecan (SN-38) conjugated to a monoclonal antibody targeting trophoblast cell surface antigen 2, an epithelial cell surface antigen overexpressed in many cancers. Because of the rapid approval of sacituzumab govitecan, there is limited available information on adverse event (AE) management with this agent. As such, this article reviews the clinical development of the drug, the AE profile, and provides recommendations regarding AE management to help optimize therapy with sacituzumab govitecan.

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

Sacituzumab Govitecan: First Approval. [2021] Sacituzumab govitecan (sacituzumab govitecan-hziy; Trodelvy™) is a Trop-2-directed antibody conjugated to a topoisomerase I inhibitor (SN-38) that is being developed by Immunomedics for the treatment of solid tumours, including breast cancer. In April 2020, sacituzumab govitecan received accelerated approval in the USA for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Sacituzumab govitecan is undergoing phase III development for breast cancer in the USA and EU, and phase II development for urothelial cancer. It is also being explored for brain metastases, glioblastoma, endometrial cancer and prostate cancer. This article summarizes the milestones in the development of sacituzumab govitecan leading to this first approval for mTNBC.

3. 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] To review the pharmacology, efficacy, and safety of sacituzumab govitecan (-hziy; IMMU-132, Trodelvy) for patients with metastatic triple-negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease.

4. 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] Sacituzumab govitecan (IMMU-132) is an antibody-drug conjugate (ADC) targeting Trop-2, a surface glycoprotein expressed on many epithelial tumors, for delivery of SN-38, the active metabolite of irinotecan. This phase I trial evaluated this ADC as a potential therapeutic for pretreated patients with a variety of metastatic solid cancers.

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

An integrated analysis of Sacituzumab govitecan in relapsed or refractory metastatic triple-negative breast cancer. [2023] Sacituzumab govitecan (SG) is an antibody-drug conjugate that targets the human trophoblast cell-surface antigen 2 to deliver SN-38 to cancer cells. In this study, we assessed the efficacy and safety of SG in patients with relapsed or refractory metastatic triple-negative breast cancer (RM-TNBC).

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

Current and emerging role of sacituzumab govitecan in the management of urothelial carcinoma. [2022] Despite rapid advances in the treatment landscape of urothelial cancer, there is a substantial unmet need for safe and effective therapies for patients with locally advanced and metastatic urothelial cancer. Sacituzumab govitecan (SG) is an antibody-drug conjugate, consisting of a Trop-2 directed monoclonal antibody linked to SN-38, the active metabolite of irinotecan. Trop-2 is a glycoprotein overexpressed in various carcinomas, including urothelial carcinomas.