What side effects are associated with this type of intervention?

Common treatments for metastatic tumors using antibody-drug conjugates (ADCs) like Sacituzumab Govitecan-hziy, which targets the Trop-2 receptor to deliver the cytotoxic agent SN-38, often have side effects including neutropenia, diarrhea, nausea, fatigue, and alopecia. These side effects are primarily due to the cytotoxic nature of the drug component (SN-38) and the targeted delivery mechanism, which can affect both cancerous and some healthy cells.

What prior FDA approvals exist?

The FDA has approved several antibody-drug conjugates (ADCs) for the treatment of metastatic tumors. One notable example is Trastuzumab emtansine (T-DM1), approved for HER2-positive metastatic breast cancer, which combines the HER2-targeting properties of trastuzumab with the cytotoxic agent DM1. Another example is Brentuximab vedotin, approved for Hodgkin lymphoma and systemic anaplastic large cell lymphoma, which targets CD30 and delivers the cytotoxic agent MMAE. These ADCs, like Sacituzumab Govitecan-hziy, utilize targeted delivery mechanisms to improve the efficacy and reduce the systemic toxicity of chemotherapy.

What other types of research exist?

Promising alternatives to Sacituzumab Govitecan-hziy for metastatic tumor patients include Trastuzumab Deruxtecan, which has shown efficacy in HER2-positive breast cancer and brain metastases, and Atezolizumab combined with Bevacizumab, which has demonstrated improved survival in advanced renal cell carcinoma. Additionally, Pembrolizumab has shown clinical efficacy in various metastatic cancers, including urothelial carcinoma and renal cell carcinoma with sarcomatoid features.

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Monoclonal Antibodies

Sacituzumab Govitecan for Metastatic Cancer (TROPiCS-03 Trial)

Phase 2

Waitlist Available

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy. No more than 3 prior lines of systemic treatment is allowed

Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1

Must not have

Have previously received topoisomerase I inhibitors

Have not recovered (i.e., ≤ Grade 1) from adverse events due to a previously administered agent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called sacituzumab govitecan-hziy in patients whose cancer has spread to other parts of their body. The medicine works by finding and attacking cancer cells with a powerful drug. Sacituzumab govitecan-hziy, approved in 2020, is used for treating metastatic triple-negative breast cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Sacituzumab Govitecan may cause nausea, diarrhea, hair loss (alopecia), fatigue, neutropenia (low white blood cell count which can increase infection risk), anemia (low red blood cell count causing tiredness) and other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My endometrial cancer worsened after treatments including platinum and anti-PD-(L)1 therapy, with no more than 3 treatments tried.

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

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

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My cancer can be measured on scans according to specific criteria.

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My cancer is advanced and has spread to other parts of my body.

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My head/neck cancer worsened after specific treatments, and I've had 3 or fewer treatments.

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My NSCLC worsened after treatments with platinum and PD-(L)1 therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been treated with topoisomerase I inhibitors before.

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I still have side effects from previous treatments that are not mild.

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I have another type of cancer that is currently active.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment

Secondary study objectives

Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR

Clinical Benefit Rate (CBR) According to RECIST 1.1 by Investigator's Assessment

DOR According to RECIST 1.1 by Investigator's Assessment

+6 more

Side effects data

From 2023 Phase 3 trial • 543 Patients • NCT03901339

54%

Neutropenia

35%

Nausea

33%

Fatigue

27%

Anaemia

24%

Constipation

23%

Diarrhoea

21%

Decreased appetite

20%

Asthenia

18%

Aspartate aminotransferase increased

18%

Alopecia

18%

Pyrexia

16%

Thrombocytopenia

16%

Vomiting

15%

Alanine aminotransferase increased

15%

Dyspnoea

14%

Abdominal pain

14%

Headache

12%

Arthralgia

12%

Lymphopenia

12%

Back pain

11%

Blood alkaline phosphatase increased

10%

Leukopenia

10%

Urinary tract infection

Insomnia

Neuropathy peripheral

Myalgia

Cough

Stomatitis

Hyperglycaemia

Blood bilirubin increased

Abdominal pain upper

Weight decreased

Palmar-plantar erythrodysaesthesia syndrome

Peripheral sensory neuropathy

Rash

Oedema peripheral

Mucosal inflammation

Paraesthesia

Bone pain

Blood lactate dehydrogenase increased

Pain in extremity

Muscle spasms

Hypokalaemia

Gastrooesophageal reflux disease

Pain

Febrile neutropenia

Hypomagnesaemia

Dizziness

Hypertension

Abdominal distension

Dyspepsia

Dry skin

Pneumonia

Dry mouth

Pruritus

Epistaxis

Confusional state

Pleural effusion

Dehydration

100%

80%

60%

40%

20%

Study treatment Arm

Treatment of Physician's Choice (TPC)

Sacituzumab Govitecan

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sacituzumab Govitecan-hziyExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacituzumab Govitecan-hziy

2021

Completed Phase 3

~580

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antibody-drug conjugates (ADCs) like Sacituzumab Govitecan-hziy are designed to target specific antigens on the surface of cancer cells, such as the Trop-2 receptor. The ADC binds to the receptor, allowing the conjugated cytotoxic agent (e.g., SN-38) to be internalized by the cancer cell. Once inside, the cytotoxic agent is released, leading to cell death. This targeted approach minimizes damage to healthy cells and enhances the efficacy of the treatment. For metastatic tumor patients, this specificity is crucial as it offers a more effective treatment option with potentially fewer side effects compared to traditional chemotherapy, thereby improving overall outcomes and quality of life.

Phase 1b study of anti-NaPi2b antibody-drug conjugate lifastuzumab vedotin (DNIB0600A) in patients with platinum-sensitive recurrent ovarian cancer.