What side effects are associated with this type of intervention?

Common treatments for Testicular Germ Cell Tumor (TGCT) include chemotherapy agents such as cisplatin, etoposide, and bleomycin. These treatments can cause a range of side effects including nausea, vomiting, hair loss, and increased risk of infections due to bone marrow suppression. Long-term side effects may include hearing loss, kidney damage, and infertility. Cyclophosphamide, another chemotherapy agent, can cause irreversible azoospermia, leading to permanent infertility. Emactuzumab, a CSF1R inhibitor, is being studied for TGCT, and while specific side effects are not detailed, similar treatments may cause immune-related adverse effects such as fatigue, rash, and potential liver enzyme abnormalities.

What prior FDA approvals exist?

FDA-approved treatments for Testicular Germ Cell Tumor typically include chemotherapy regimens such as bleomycin, etoposide, and cisplatin (BEP). These treatments are not directly related to CSF1R inhibition, which is the mechanism of action for Emactuzumab. Currently, there are no FDA-approved CSF1R inhibitors specifically for Testicular Germ Cell Tumor. The focus remains on traditional chemotherapy and, in some cases, surgical intervention.

What other types of research exist?

Promising novel alternatives to Emactuzumab for Testicular Germ Cell Tumor patients include immune checkpoint inhibitors (such as pembrolizumab and nivolumab), targeted therapies (like cabozantinib and regorafenib), and combination therapies involving these agents. These treatments have shown efficacy in various types of cancers and are being explored in clinical trials for their potential use in TGCT.

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Monoclonal Antibodies

Emactuzumab for Giant Cell Tumor (TANGENT Trial)

Phase 3

Recruiting

Led By Jean Y Blay, Prof, MD

Research Sponsored by SynOx Therapeutics Limited

Eligibility Criteria Checklist

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

Must have

Biopsy-confirmed local or diffuse TGCT with predicted worsening functional limitations through surgical joint damage or high risk of early recurrence

Age >12 years

Must not have

Current or chronic history of liver disease

Medical conditions requiring systemic immunosuppression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Pivotal Trial

Summary

This trial tests emactuzumab, a new treatment for patients with TGCT tumors that can't be removed by surgery. The drug aims to control or reduce tumor growth by targeting the tumor cells.

Who is the study for?

This trial is for individuals over 12 with TGCT where surgery could worsen joint function or has high recurrence risk, and who can't have improved outcomes from surgery. Participants need proper organ/bone marrow function, a negative pregnancy test for women of childbearing age, and must agree to use effective contraception.

What is being tested?

The study tests emactuzumab's effectiveness and safety in treating TGCT when surgery isn't an option. It's a double-blind trial comparing emactuzumab with placebo given as an IV every two weeks for five sessions, followed by observation and long-term follow-up phases.

What are the potential side effects?

While specific side effects are not listed here, participants will undergo regular health checks including blood tests and electrocardiograms to monitor any adverse reactions to the treatment.

Eligibility Criteria

Inclusion Criteria

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

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My biopsy shows TGCT that could worsen my joint function or recur quickly.

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I am older than 12 years.

Exclusion Criteria

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

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I have a history of liver disease.

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I am on medication that weakens my immune system.

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I have metastatic TGCT or another cancer needing treatment.

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I have been on antiretroviral therapy in the last 3 months.

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I don't have ongoing major side effects from past treatments or serious liver issues.

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My kidney and liver are not working well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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

Overall Response Rate (ORR)

Secondary study objectives

Duration of response (DoR)

Physical Function

Quality of Life (QoL)

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1 in Part 1/Part 2: EmactuzumabExperimental Treatment1 Intervention

Group 1: Subjects receiving emactuzumab administered intravenously (i.v) on Day(D)1 and repeated once every two weeks (Q2W) for a total of 5 times, followed by an observation period of 3 months leading to a total period of 24 weeks in Part 1 and continued with a follow-up phase in Part 2. Eligible Subjects assigned to active drug in Part 1 have the option to receive open-label retreatment in Part 2.

Group II: Group 2 in Part 1 and Part 2: PlaceboPlacebo Group1 Intervention

Group 2: Subjects receiving placebo administered intravenously (i.v) on D1 and repeated once every two weeks (Q2W) for 5 times followed by an observation period of 3 months to a total period of 24 weeks in Part 1. In Part 2, Eligible Subjects will have the option to receive open-label emactuzumab, administered by i.v once every 2 weeks (Q2W) for a total of 5 times.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Emactuzumab

Not yet FDA approved

0 / 8Eligibility 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

The most common treatments for Testicular Germ Cell Tumor (TGCT) include chemotherapy agents such as cisplatin, etoposide, and bleomycin. Cisplatin works by forming DNA crosslinks, which inhibit DNA synthesis and function, leading to cell death. Etoposide inhibits topoisomerase II, preventing DNA unwinding and replication, while bleomycin induces DNA strand breaks. These mechanisms are crucial for TGCT patients as they target rapidly dividing cancer cells, leading to tumor reduction. Emactuzumab, an investigational drug, targets the colony-stimulating factor 1 receptor (CSF1R), which is involved in the regulation of macrophages in the tumor microenvironment. By inhibiting CSF1R, emactuzumab may reduce tumor-associated macrophages, potentially enhancing anti-tumor immune responses and improving treatment outcomes for patients with TGCT.