Sacituzumab Govitecan for Cancer

Recruiting at 7 trial locations

Overseen By Gilead Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Gilead Sciences

Must not be taking: Irinotecan, UGT1A1 inhibitors

Disqualifiers: Active CNS metastases, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of the drug sacituzumab govitecan-hziy (Trodelvy) for individuals with advanced solid tumors, specifically targeting those with moderate liver issues. Participants will receive the drug to observe bodily reactions and determine the optimal dosage. This trial suits individuals with advanced or metastatic solid tumors affecting daily life, who have either moderate liver impairment or normal liver function. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially groundbreaking therapy.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot have had certain cancer treatments recently or use strong inhibitors or inducers of UGT1A1. It's best to discuss your current medications with the study team.

Is there any evidence suggesting that sacituzumab govitecan-hziy is likely to be safe for humans?

Research has shown that sacituzumab govitecan is generally well-tolerated by people with advanced cancers. Studies have found that patients often manage its side effects well. Common side effects include low white blood cell counts, diarrhea, and fatigue, but these are usually manageable with standard care.

One study found that patients with advanced cancer who had tried many other treatments did not find the side effects of sacituzumab govitecan severe enough to stop treatment.

This medication has been tested in different groups, including those with liver issues, similar to the focus of the current trial. Overall, existing data suggest that sacituzumab govitecan can be used safely in various cancer patients, though individual experiences may differ. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Sacituzumab govitecan-hziy is unique because it combines an antibody with a chemotherapy agent, specifically targeting cancer cells with Trop-2 proteins, common in many tumors. This targeted approach allows for direct delivery of the chemotherapy to cancer cells, potentially reducing damage to healthy cells and improving effectiveness. Researchers are excited about its potential to treat patients with advanced or metastatic solid tumors, especially those with liver impairments, as it offers a new mechanism of action compared to traditional chemotherapies that do not differentiate between cancerous and healthy cells.

What evidence suggests that sacituzumab govitecan-hziy might be an effective treatment for solid tumors?

Research has shown that sacituzumab govitecan may help treat various solid tumors. This treatment targets cancer cells and delivers a potent anti-cancer drug directly to them. In this trial, participants with advanced or metastatic solid tumors will receive sacituzumab govitecan-hziy, with dosing adjusted based on liver function. Studies have found it generally safe and predictable at doses similar to those being tested. The treatment demonstrated promising results in patients with advanced cancers, especially when other treatments proved ineffective. This suggests it could be a valuable option for people with hard-to-treat cancers. ^{2 3 4 6 7}

Who Is on the Research Team?

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors and moderate liver impairment. They should have a certain level of liver function, no severe active infections, and not be on strong inhibitors or inducers of UGT1A1. Participants must not have had recent cancer treatments that they haven't recovered from, nor can they have brain metastases unless stable.

Inclusion Criteria

Normal hepatic function (total bilirubin ≤ ULN and aspartate aminotransferase [AST] ≤ 3.0× ULN) for individuals with normal hepatic function

Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

Moderate hepatic impairment (1.5 × ULN < total bilirubin < 3.0 × ULN and any level of AST) for individuals with moderate hepatic function

Exclusion Criteria

Individuals with transjugular intrahepatic portosystemic shunt (TIPS) placement

Have active Stage 3 or 4 encephalopathy

Had prior treatment with irinotecan within 4 weeks prior to Day 1

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sacituzumab govitecan-hziy on Days 1 and 8 with dose escalation from 5 mg/kg to 10 mg/kg

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may continue to receive treatment in a Gilead sponsored rollover study if deriving benefit

What Are the Treatments Tested in This Trial?

Interventions

• Sacituzumab Govitecan-hziy

Trial Overview The study tests the safety and appropriate dosing of Sacituzumab Govitecan-hziy in patients with various solid tumors who also suffer from moderate liver problems. It aims to understand how these patients tolerate the drug and how it affects their disease.

How Is the Trial Designed?

Group I: Advanced or Metastatic Solid Tumor and Normal Liver function Experimental Treatment 1 Intervention

Participants with advanced or metastatic solid tumor and normal hepatic function will receive sacituzumab govitecan-hziy 10 mg/kg on Days 1 and 8. At the completion of study treatment, participants who are deriving benefit from sacituzumab govitecan-hziy may continue to receive treatment in a Gilead sponsored rollover study (IMMU-132-14; NCT04319198).

Group II: Advanced or Metastatic Solid Tumor and Moderate Liver Impairment Experimental Treatment 1 Intervention

Participants with advanced solid tumor and moderate hepatic impairment will receive an escalating dose of sacituzumab govitecan-hziy on Days 1 and 8. The dose-escalation plan will start at 5 mg/kg and escalate to 7.5 mg/kg, and finally 10 mg/kg, if deemed to be safe. At the completion of study treatment, participants who are deriving benefit from sacituzumab govitecan-hziy may continue to receive treatment in a Gilead sponsored rollover study (IMMU-132-14; NCT04319198).

Sacituzumab Govitecan-hziy 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
• Metastatic urothelial cancer
• Metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative 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

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

In a phase 1/2 trial involving 108 patients with heavily pretreated metastatic triple-negative breast cancer, sacituzumab govitecan-hziy demonstrated a response rate of 33.3%, with a median duration of response of 7.7 months, indicating its efficacy in this challenging patient population.

The treatment was associated with significant myelotoxic effects, including anemia and neutropenia, but overall survival was promising at a median of 13.0 months, highlighting the need for careful monitoring of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. Bardia, A., Mayer, IA., Vahdat, LT., et al.[2019]

Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2 and delivers a topoisomerase I inhibitor, showing promise in treating metastatic triple-negative breast cancer (mTNBC) after at least two prior therapies.

In April 2020, it received accelerated approval in the USA for mTNBC, and it is currently undergoing further clinical trials for various cancers, indicating its potential as a versatile treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Sacituzumab govitecan (IMMU-132) demonstrated a predictable pharmacokinetic profile and manageable toxicity in patients with advanced epithelial cancers, with doses of 8 mg/kg (n=81) and 10 mg/kg (n=97) showing safety and efficacy.

The treatment resulted in objective responses in various cancer types, particularly metastatic triple-negative breast cancer, supporting the use of the 10 mg/kg dose for future clinical development.

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]

Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2 and has shown a 33.3% overall response rate in patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies, based on a phase I/II study with 108 participants.

The treatment has a median duration of response of 7.7 months, and while it is generally well-tolerated, common side effects include nausea, neutropenia, and fatigue, indicating a need for monitoring during treatment.

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, an antibody-drug conjugate targeting Trop-2, showed promising therapeutic activity in a phase I trial with 25 patients suffering from various metastatic solid cancers, achieving partial responses in two patients and stable disease in 16 others.

The maximum tolerated dose was determined to be 12 mg/kg for the first cycle, with lower doses (8 and 10 mg/kg) being safer for extended treatment, leading to acceptable toxicity levels and disease control for up to 36 weeks.

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]

Sacituzumab govitecan (TRODELVY) is an effective treatment for metastatic triple-negative breast cancer, showing promising results in a phase I/II study and receiving accelerated FDA approval for patients who have undergone at least two prior therapies.

The drug has a well-defined and manageable toxicity profile, and proactive management of adverse events is crucial for optimizing treatment duration and maintaining patient quality of life.

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]

Sacituzumab govitecan (IMMU-132) has been shown to prolong progression-free survival in patients with advanced triple-negative breast cancer, indicating its efficacy as a treatment option.

The treatment is well tolerated, resulting in fewer and more manageable side effects compared to traditional irinotecan, suggesting a safer profile for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An ADC for Triple-Negative Breast Cancer. [2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28558150/

Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 ... Sacituzumab govitecan has a predictable pharmacokinetic profile and manageable toxicity at doses of 8 and 10 mg/kg.

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2511734

Sacituzumab Govitecan in Untreated, Advanced Triple- ... Here, we report the primary results from the ASCENT-03 trial of sacituzumab govitecan as compared with chemotherapy for the first-line treatment ...

3. aacrjournals.org aacrjournals.org/clincancerres/article/31/8/1390/754522/The-Mode-of-Action-and-Clinical-Outcomes-of

The Mode of Action and Clinical Outcomes of Sacituzumab ... This review will provide an overview of SG in solid tumors, focusing on its mode of action. SG. SG emerged as an effective trophoblast cell-surface antigen-2 ( ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03964727

NCT03964727 | Study of Sacituzumab Govitecan in ... The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy, in participants with metastatic (cancer that has spread) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11458108/

Efficacy and Safety of Sacituzumab Govitecan in Patients With ... Findings from TROPiCS-03 showed encouraging efficacy of SG with a manageable toxicity profile in a heavily pretreated population with advanced EC.

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3029

Pooled safety analysis of sacituzumab govitecan (SG) in ... Methods: Safety data for pts treated with SG (10 mg/kg, days 1 and 8 every 21-day cycle) were pooled from 4 clinical trials of multiple solid ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0923753421008838

Sacituzumab govitecan, a Trop-2-directed antibody-drug ... This report summarizes the safety data from the overall safety population (OSP) and efficacy data, including additional disease cohorts not published previously ...