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}

Research Team

Alessandro Santin

Principal Investigator

Yale University

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 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:

Smilow Cancer Hospital at Yale New Haven New Haven, CT

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1963

Patients Recruited

3,046,000+

Alessandro Santin

Lead Sponsor

Trials

4

Patients Recruited

140+

Gilead Sciences

Industry Sponsor

Trials

1150

Patients Recruited

878,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan for Metastatic Triple-Negative Breast Cancer: Clinical Overview and Management of Potential Toxicities. Spring, LM., Nakajima, E., Hutchinson, J., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and emerging role of sacituzumab govitecan in the management of urothelial carcinoma. Mathew Thomas, V., Tripathi, N., Agarwal, N., et al.[2022]

References

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

Sacituzumab Govitecan for Metastatic Triple-Negative Breast Cancer: Clinical Overview and Management of Potential Toxicities. [2021]

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

Sacituzumab Govitecan: First Approval. [2021]

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]

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]

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

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

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

Current and emerging role of sacituzumab govitecan in the management of urothelial carcinoma. [2022]