Sacituzumab Govitecan for Endometrial Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Alessandro Santin
Must not be taking: Antiretrovirals, Antiarrhythmics
Disqualifiers: Active second malignancy, Cardiac disease, COPD, 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 persistent or recurrent endometrial carcinoma.
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 need to be at least 2 weeks beyond any prior treatments like chemotherapy, investigational drugs, or high-dose corticosteroids before starting the trial.
What data supports the effectiveness of the drug Sacituzumab Govitecan for endometrial cancer?
Sacituzumab Govitecan has shown promising results in laboratory studies for uterine serous carcinoma, a type of endometrial cancer, by targeting a specific protein on cancer cells to deliver a cancer-fighting substance. Additionally, it has been effective in treating other cancers like triple-negative breast cancer, which suggests potential benefits for endometrial cancer as well.
12345What safety data exists for Sacituzumab Govitecan in humans?
Sacituzumab Govitecan has shown acceptable safety in clinical trials for various cancers, including breast cancer, with a well-defined and manageable toxicity profile. Rapid recognition and proactive management of side effects are important to optimize treatment and maintain quality of life.
34678What makes the drug Sacituzumab Govitecan unique for treating endometrial cancer?
Sacituzumab Govitecan is unique because it is an antibody-drug conjugate that specifically targets the Trop-2 protein, which is often overexpressed in aggressive forms of endometrial cancer, to deliver a potent chemotherapy agent directly to cancer cells, potentially improving treatment effectiveness.
34569Eligibility Criteria
This trial is for adults with persistent or recurrent endometrial carcinoma that worsened after platinum-based chemotherapy. They must have measurable disease, adequate organ function, and an ECOG performance status of 0 or 1. Participants need to be at least two weeks past prior treatments and recovered from acute toxicities. Pregnant women are excluded, as well as those with active second cancers, significant heart conditions, unstable medical issues, CNS metastases, certain viral infections, bleeding disorders or a history of severe reactions to similar drugs.Inclusion Criteria
My liver functions are within the required range.
Patients must have signed an approved informed consent.
I can provide a sample of my tumor for TROP-2 testing.
+17 more
Exclusion Criteria
I have stable brain metastases, not on high steroids, and no carcinomatous meningitis.
I have HIV with a high viral load and take medication that could affect my treatment.
I do not have an active second cancer, or it has been in remission for over 3 years.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Sacituzumab govitecan is administered at 10 mg/kg weekly as an infusion for 2 consecutive weeks followed by 1 week without treatment, representing a 3-week cycle. Treatment continues in the absence of disease progression or unacceptable toxicity.
Until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments including adverse events and survival outcomes.
6 years
Participant Groups
The study tests Sacituzumab Govitecan (IMMU-132) in patients with endometrial cancer that has returned or persisted despite previous treatment. It's a Phase 2 trial where all participants receive the drug without being randomly assigned to different groups.
1Treatment groups
Experimental Treatment
Group I: Sacituzumab GovitecanExperimental Treatment1 Intervention
Sacituzumab govitecan will be administered at 10 mg/kg weekly as an infusion for 2 consecutive weeks (2 weekly doses plus 1 week without treatment represents a single 3 week cycle). Treatment can be continued without a rest period in the absence of progression of disease or unacceptable toxicity.
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 NearbySelect from list below to view details:
Smilow Cancer Hospital at Yale New HavenNew Haven, CT
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Who Is Running the Clinical Trial?
Alessandro SantinLead Sponsor
Yale UniversityLead Sponsor
Gilead SciencesIndustry Sponsor
References
Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: Safety and pharmacokinetics. [2018]Sacituzumab govitecan (IMMU-132), an antitrophoblastic cell-surface antigen (anti-Trop-2) humanized antibody-SN-38 conjugate, had encouraging efficacy in the phase 1 clinical trial. This report further examines the pharmacokinetics and safety of multiple cycles of IMMU-132 at doses of 8 or 10 mg/kg in patients with diverse advanced epithelial cancers.
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.
In vitro and in vivo activity of sacituzumab govitecan, an antibody-drug conjugate targeting trophoblast cell-surface antigen 2 (Trop-2) in uterine serous carcinoma. [2020]Uterine serous carcinoma (USC) is an aggressive variant of endometrial cancer with poor prognosis. Sacituzumab govitecan (SG) is a novel antibody-drug-conjugate (ADC) targeting trophoblast cell-surface antigen 2 (Trop-2), a transmembrane-calcium-signal-transducer, to deliver SN-38, the active metabolite of irinotecan. The objective of this study was to evaluate the expression of Trop-2 in USC and the preclinical activity of SG against primary USC cell-lines and xenografts.
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).
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.
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.
Sacituzumab govitecan, a Trop-2-directed antibody-drug conjugate, for patients with epithelial cancer: final safety and efficacy results from the phase I/II IMMU-132-01 basket trial. [2021]Sacituzumab govitecan (SG), a trophoblast cell surface antigen-2 (Trop-2)-directed antibody-drug conjugate, has demonstrated antitumor efficacy and acceptable tolerability in a phase I/II multicenter trial (NCT01631552) in patients with advanced epithelial cancers. This report summarizes the safety data from the overall safety population (OSP) and efficacy data, including additional disease cohorts not published previously.
Assessing real-world safety concerns of Sacituzumab govitecan: a disproportionality analysis using spontaneous reports in the FDA adverse event reporting system. [2023]The aim of this study was to identify potential safety concerns associated with Sacituzumab Govitecan (SG), an antibody-drug conjugate targeting trophoblastic cell-surface antigen-2, by analyzing real-world safety data from the largest publicly available worldwide pharmacovigilance database.
TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors. [2022]Patients with metastatic urothelial carcinoma (mUC) who progress on platinum-based combination chemotherapy (PLT) and checkpoint inhibitors (CPIs) have limited options that offer objective response rates (ORRs) of approximately 10% with a median overall survival (OS) of 7-8 months. Sacituzumab govitecan (SG) is a TROP-2-directed antibody-drug conjugate with an SN-38 payload that has shown preliminary activity in mUC.