What is the mechanism of action of this treatment?

The most common treatments for Glioblastoma include temozolomide, which works by alkylating DNA and inducing cell death, and radiation therapy, which destroys cancer cells with high-energy particles. Immune checkpoint inhibitors, such as anti-PD-1/PD-L1, enhance the immune system's ability to target cancer cells. Investigational agents like TAS2940 may target specific molecular pathways critical for tumor growth and survival. Understanding these mechanisms is essential for optimizing treatment strategies and developing new therapies to overcome resistance in Glioblastoma patients.

What side effects are associated with this type of intervention?

Common treatments for Glioblastoma, such as temozolomide and bevacizumab, are associated with several side effects. Temozolomide can cause nausea, vomiting, fatigue, and myelosuppression, leading to increased risk of infection. Bevacizumab, an angiogenesis inhibitor, may result in hypertension, proteinuria, and increased risk of bleeding and thromboembolic events. Investigational agents like TAS2940, while still under study, may share similar side effects, including gastrointestinal disturbances, fatigue, and hematologic toxicities. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including temozolomide, which is an oral alkylating agent used in combination with radiation therapy and as maintenance therapy. Another treatment, bevacizumab, a monoclonal antibody that inhibits vascular endothelial growth factor (VEGF), has been approved for recurrent Glioblastoma. Additionally, the investigational agent tirapazamine has been studied in combination with radiation therapy for Glioblastoma, although it is not yet FDA-approved. These treatments aim to target the aggressive nature of Glioblastoma by inhibiting tumor growth and proliferation.

What other types of research exist?

Promising novel alternatives to TAS2940 for glioblastoma patients include: 1) Temozolomide, which remains a cornerstone in glioblastoma treatment, often used in combination with radiotherapy. 2) Bevacizumab, although it failed to show a survival advantage, it is still used for its ability to manage symptoms and improve quality of life. 3) Alternating Electric Fields Therapy (NovoTTF-100A), approved by the FDA for recurrent glioblastoma, offers a non-invasive treatment option. 4) Immunotherapy agents such as PD-1 inhibitors (e.g., nivolumab) are being explored for their potential benefits in glioblastoma. 5) Combination therapies involving radiotherapy and novel drugs are also under investigation to improve outcomes.

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TAS2940 for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by Taiho Oncology, Inc.

Eligibility Criteria Checklist

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

Must have

For Dose Escalation: Any solid tumor with EGFR and/or HER2 aberration

Have histologically confirmed solid cancer that is locally advanced and metastatic and available standard treatment options have been exhausted

Must not have

Have significant cardiovascular disorder

Non-stable brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests TAS2940, a new drug for patients with advanced cancers who have no other treatment options. TAS2940 works by blocking proteins that help cancer cells grow. It is effective against certain types of tumors.

Who is the study for?

This trial is for people with advanced solid tumors like breast cancer, lung cancer, or glioblastoma who have no remaining standard treatment options. Participants must have a certain type of tumor change (EGFR/HER2), measurable disease, good organ function and be in fair physical shape (ECOG PS 0-1). Those with unstable brain metastases, serious heart issues or unresolved effects from past cancer treatments cannot join.

What is being tested?

The study tests TAS2940's safety and effectiveness on various cancers without available therapies. It's an early-stage trial to see how the body handles the drug (pharmacokinetics/dynamics) and its initial success in shrinking tumors across different patient groups divided by their specific cancer types.

What are the potential side effects?

As this is a first-in-human study for TAS2940, detailed side effects are not yet known but may include typical reactions seen with other cancer drugs such as nausea, fatigue, allergic reactions and potential impacts on blood counts or organ functions.

Eligibility Criteria

Inclusion Criteria

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

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My solid tumor has EGFR or HER2 changes.

Select...

My cancer is advanced, has spread, and no standard treatments are left.

Select...

I am fully active or can carry out light work.

Exclusion Criteria

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

Select...

I have a serious heart condition.

Select...

My brain cancer has not remained the same and is getting worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ estimated up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~estimated up to 6 months

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

Dose Escalation:Maximum Tolerated Dose (MTD)

Dose Expansion:Overall Response Rate

Secondary study objectives

Dose Escalation: Overall Response Rate (ORR)

Dose Escalation:Pharmacokinetic (PK) Profile

Dose Expansion:Disease Control Rate (DCR)

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: TAS2940 Dose EscalationExperimental Treatment1 Intervention

Dose escalation will assess the safety and determine the maximum tolerated dose, the recommended phase 2 dose and the recommended dosing regimen of TAS2940 administered orally.

Group II: Dose Expansion Solid tumorsExperimental Treatment1 Intervention

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.

Group III: Dose Expansion Non-small Cell Lung CancerExperimental Treatment1 Intervention

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations

Group IV: Dose Expansion GliblastomaExperimental Treatment1 Intervention

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.

Group V: Dose Expansion Breast CancerExperimental Treatment1 Intervention

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations

0 / 5Eligibility 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 Glioblastoma include temozolomide, which works by alkylating DNA and inducing cell death, and radiation therapy, which destroys cancer cells with high-energy particles. Immune checkpoint inhibitors, such as anti-PD-1/PD-L1, enhance the immune system's ability to target cancer cells. Investigational agents like TAS2940 may target specific molecular pathways critical for tumor growth and survival. Understanding these mechanisms is essential for optimizing treatment strategies and developing new therapies to overcome resistance in Glioblastoma patients.