What is the mechanism of action of this treatment?

Glioblastoma treatments typically include surgery, radiation therapy, and chemotherapy. Surgery aims to remove as much of the tumor as possible, reducing mass effect and symptoms. Radiation therapy uses high-energy beams to damage the DNA of cancer cells, inhibiting their ability to replicate. Chemotherapy, such as temozolomide, works by alkylating/methylating DNA, leading to cell death. Investigational agents, like those in clinical trials, often target specific molecular pathways involved in tumor growth and survival, such as inhibiting angiogenesis or specific oncogenes. Understanding these mechanisms is crucial for Glioblastoma patients as it helps in selecting personalized treatment plans and improving outcomes by targeting the tumor more effectively.

What side effects are associated with this type of intervention?

Common treatments for Glioblastoma, including chemotherapy and investigational agents, often result in side effects such as fatigue, nausea, vomiting, and hematologic toxicities like neutropenia and anemia. Patients may also experience neurotoxicity, leading to symptoms such as peripheral neuropathy. Targeted therapies can cause specific adverse events like skin reactions, hypomagnesemia, and infusion-related reactions. Overall, while these treatments can be effective, they are associated with a range of mild to severe side effects that require careful management.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including temozolomide, an oral alkylating agent that interferes with DNA replication, and bevacizumab, a monoclonal antibody that inhibits vascular endothelial growth factor (VEGF) to prevent tumor angiogenesis. These treatments aim to slow tumor growth and manage symptoms. Other investigational agents and combination therapies continue to be explored in clinical trials to improve outcomes for patients with Glioblastoma.

What other types of research exist?

Promising novel alternatives for glioblastoma treatment in 2024 include: 1) Bevacizumab, an angiogenesis inhibitor, often combined with other chemotherapeutic agents. 2) Ivosidenib, a mutant-IDH1 inhibitor, showing promise in clinical trials for IDH1-mutant gliomas. 3) Vorasidenib, a dual mutant-IDH1/2 inhibitor, currently in phase III trials. 4) Immunotherapies such as PD-1 inhibitors (e.g., nivolumab) for patients with specific genetic profiles. These options represent the forefront of glioblastoma treatment advancements.

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Monoclonal Antibodies

Sacituzumab Govitecan for Glioblastoma

Phase 2

Recruiting

Led By Andrew Brenner, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

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

Must have

Recovered from toxicities of prior therapy to grade 0 or 1, except for neuropathy (≤Grade 2) and alopecia.

Histologically confirmed IDH wild-type (de novo) GBM

Must not have

The subject has serious intercurrent illness, such as: hypertension (two or more blood pressure [BP] readings performed at screening of > 150 mmHg systolic or > 100 mmHg diastolic) despite optimal treatment, non-healing wound, ulcer, or bone fracture, significant cardiac arrhythmias, untreated hypothyroidism, unhealed rectal or peri-rectal abscess, uncontrolled active infection, symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug any history of cardiac arrhythmia or heart block, stroke or transient ischemic attack within 6 months

The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment or drug on all patients in the study to see if it is effective and safe.

Who is the study for?

Adults with confirmed IDH wild-type glioblastoma that has progressed after standard treatment, including radiation and chemotherapy. Participants must have stable vital signs, acceptable blood counts, liver and kidney function, agree to use contraception, and not be pregnant or breastfeeding. They should not have had certain recent treatments or surgeries and must be willing to stop using tumor treatment field therapy.

What is being tested?

The trial is testing Sacituzumab Govitecan as a single agent in an open-label setting for recurrent glioblastoma patients. Everyone in the study will receive this investigational drug to evaluate its effectiveness against this type of brain cancer.

What are the potential side effects?

While specific side effects for Sacituzumab Govitecan are not listed here, common ones may include nausea, fatigue, hair loss (alopecia), low blood cell counts leading to increased infection risk or bleeding problems. Organ-specific inflammation could also occur.

Eligibility Criteria

Inclusion Criteria

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

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I have recovered from previous treatment side effects, except for mild neuropathy or hair loss.

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My glioblastoma is confirmed to be IDH wild-type.

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My liver function tests are within the required range.

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I am 18 years old or older.

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My kidneys work well enough (creatinine clearance ≥30 mL/min).

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I am willing to not use Optune therapy while in this study.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

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

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I have a serious health condition like uncontrolled high blood pressure or heart issues.

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I am taking warfarin or similar drugs and cannot switch to LMWH before starting the study drug.

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I have been treated with medications targeting blood vessel growth in cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression free survival

Side effects data

From 2020 Phase 3 trial • 529 Patients • NCT02574455

40%

Fatigue

30%

Nausea

27%

Anaemia

25%

Neutropenia

23%

Constipation

21%

Decreased appetite

20%

Neutrophil count decreased

18%

Cough

18%

Dyspnoea

17%

Diarrhoea

16%

Alopecia

16%

Vomiting

13%

Hypokalaemia

13%

Headache

13%

Back pain

13%

Asthenia

12%

Pyrexia

12%

Aspartate aminotransferase increased

11%

Oedema peripheral

11%

Neuropathy peripheral

10%

Alanine aminotransferase increased

10%

White blood cell count decreased

Urinary tract infection

Myalgia

Pain in extremity

Platelet count decreased

Arthralgia

Dizziness

Abdominal pain

Weight decreased

Mucosal inflammation

Lymphocyte count decreased

Bone pain

Hypomagnesaemia

Hypertension

Thrombocytopenia

Stomatitis

Insomnia

Pain

Rash

Blood alkaline phosphatase increased

Hyperglycaemia

Oropharyngeal pain

Hypophosphataemia

Anxiety

Abdominal pain upper

Breast pain

Upper respiratory tract infection

Musculoskeletal chest pain

Dysgeusia

Lymphoedema

Pruritus

Pleural effusion

Gastrooesophageal reflux disease

Chills

Nasopharyngitis

Hypocalcaemia

Febrile neutropenia

Sepsis

Pneumonia

Nasal congestion

Dyspnoea exertional

Dry skin

Rash maculo-papular

Pericardial effusion

Pulmonary embolism

Respiratory failure

Cellulitis

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 govitecanExperimental Treatment1 Intervention

Dosing will be at 10 mg/kg on days 1 and 8 of a 21-day cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacituzumab Govitecan

2019

Completed Early Phase 1

~30

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

Glioblastoma treatments typically include surgery, radiation therapy, and chemotherapy. Surgery aims to remove as much of the tumor as possible, reducing mass effect and symptoms. Radiation therapy uses high-energy beams to damage the DNA of cancer cells, inhibiting their ability to replicate. Chemotherapy, such as temozolomide, works by alkylating/methylating DNA, leading to cell death. Investigational agents, like those in clinical trials, often target specific molecular pathways involved in tumor growth and survival, such as inhibiting angiogenesis or specific oncogenes. Understanding these mechanisms is crucial for Glioblastoma patients as it helps in selecting personalized treatment plans and improving outcomes by targeting the tumor more effectively.