Sacituzumab Govitecan for Metastatic Cancer

(TROPiCS-03 Trial)

Not currently recruiting at 75 trial locations

Overseen By Gilead Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Gilead Sciences

Must not be taking: Topoisomerase inhibitors, Biologics

Disqualifiers: Active CNS metastases, Second malignancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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: Unknown

Duration: Up to 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called sacituzumab govitecan-hziy (an antibody-drug conjugate) for individuals with certain advanced cancers that have spread, such as lung, head and neck, endometrial, and small cell lung cancers. The goal is to evaluate the effectiveness of this treatment after other treatments have failed to halt cancer growth. Participants should have these specific cancers that have worsened despite prior chemotherapy and immunotherapy, and they must be in good general health. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Will I have to stop taking my current medications?

The trial requires that you have not taken any anti-cancer biologic agents within 4 weeks or chemotherapy, targeted therapy, or radiation therapy within 2 weeks before starting the study. This means you may need to stop certain cancer treatments before joining the trial.

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

Research has shown that sacituzumab govitecan-hziy is generally safe for people. One study focused on safety and found that patients could use it without major problems. Another study examined its safety in individuals with endometrial cancer and found it manageable for most.

Additionally, the FDA has approved sacituzumab govitecan for other cancers, such as metastatic triple-negative breast cancer. This approval indicates it has passed strict safety tests for those uses. While side effects can occur, they are usually manageable. Always consult your healthcare provider for personal advice. ^{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-drug conjugate approach, which targets and delivers chemotherapy directly to cancer cells, minimizing damage to healthy cells. Unlike standard treatments like traditional chemotherapy and immunotherapy, this drug specifically targets the Trop-2 protein, which is often overexpressed in certain cancers like non-small cell lung cancer and metastatic small cell lung cancer. This targeted action not only aims to improve effectiveness but also hopes to reduce side effects, making it a promising option for patients with advanced stages of these cancers. Researchers are excited because it represents a more focused attack on cancer cells, potentially leading to better patient outcomes.

What evidence suggests that sacituzumab govitecan-hziy might be an effective treatment for metastatic cancer?

Research has shown that sacituzumab govitecan-hziy, the treatment under study in this trial, yields promising results for certain types of advanced cancer that have spread. In one study, patients with this cancer type who received sacituzumab govitecan-hziy lived an average of 12.1 months, compared to 6.7 months for those on standard chemotherapy. Thus, patients treated with sacituzumab govitecan-hziy lived nearly twice as long as those receiving traditional chemotherapy. The treatment targets a protein called Trop-2, often found in large amounts on cancer cells, allowing it to deliver cancer-fighting drugs directly to the tumor. These findings suggest that sacituzumab govitecan-hziy could be a strong option for those dealing with aggressive cancers that have spread. ^{1 4 5 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 solid tumors that have spread, who are relatively active and can perform daily activities. They must have measurable disease, adequate blood counts, liver and kidney function, a life expectancy of at least 3 months, and specific treatment histories depending on their cancer type.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My small cell lung cancer has worsened after initial treatments including platinum and PD-(L)1 therapy.

You are expected to live for at least 3 more months.

Exclusion Criteria

I have stable brain metastases, not on high steroids, and no carcinomatous meningitis.

Additional cohort specific exclusion criteria

I have been treated with topoisomerase I inhibitors before.

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 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle until disease progression, toxicity, or withdrawal of consent

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sacituzumab Govitecan-hziy

Trial Overview The study is testing Sacituzumab Govitecan-hziy in participants with metastatic solid tumors to understand its effects better. It's given to those whose cancer has worsened despite previous treatments.

How Is the Trial Designed?

Group I: Sacituzumab Govitecan-hziy Experimental Treatment 1 Intervention

Participants with non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), endometrial cancer, or metastatic small cell lung cancer (mSCLC) will receive sacituzumab govitecan-hziy 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent.

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

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 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 (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]

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 (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 (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]

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]

Citations

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

Efficacy and Safety of Sacituzumab Govitecan in Patients With ... In the ASCENT phase III trial, overall survival (OS) was significantly longer with SG (12.1 months) than with chemotherapy (6.7 months) in ...

2. 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) ...

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

Sacituzumab Govitecan in Untreated, Advanced Triple- ... Real-world studies have shown that approximately 50% of patients with this aggressive disease do not receive a second line of treatment (owing ...

4. onclive.com onclive.com/view/ascent-gyn-01-trial-of-sacituzumab-govitecan-aims-to-validate-clinical-utility-of-trop2-adcs-in-pretreated-endometrial-cancer

ASCENT-GYN-01 Trial of Sacituzumab Govitecan Aims to ... Despite recent therapeutic advances, the association between recurrent or metastatic endometrial cancer continues and poor outcomes persists ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12173046/

Effectiveness of sacituzumab govitecan and management ... We describe the real-world effectiveness of SG as 2L+ mTNBC treatment and the proportion of patients with neutropenia and its management.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01631552

Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults ... The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day ...

7. askgileadmedical.com askgileadmedical.com/docs/trodelvy/trodelvy-use-in-endometrial-cancer

Trodelvy® Use in Patients With Endometrial Cancer Efficacy and safety of sacituzumab govitecan in patients with advanced solid tumors (TROPiCS-03): analysis in patients with advanced endometrial cancer.