What side effects are associated with this type of intervention?

Common treatments for Germ Cell Tumors, such as chemotherapy and targeted therapies, often have a range of side effects. Chemotherapy can lead to myelosuppression, resulting in anemia, neutropenia, and thrombocytopenia. Patients may also experience gastrointestinal issues like nausea, vomiting, and diarrhea, as well as alopecia and mucositis. Targeted therapies, depending on their mechanism, can cause specific organ toxicities, such as hepatotoxicity or nephrotoxicity, and may also lead to fatigue, skin rashes, and hypertension. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

FDA-approved treatments for Germ Cell Tumors typically include chemotherapeutic agents such as cisplatin, etoposide, and bleomycin, which are often used in combination regimens like BEP (Bleomycin, Etoposide, and Cisplatin). These drugs work by interfering with the DNA replication process, thereby inhibiting tumor growth. Additionally, high-dose chemotherapy followed by stem cell transplant is another approved approach for refractory or relapsed cases. While the specific mechanism of DS-9606a is not detailed, it is important to consult with a healthcare provider to understand how emerging treatments may fit into the current therapeutic landscape.

What other types of research exist?

Promising novel alternatives to DS-9606a for Germ Cell Tumors patients considering treatment in 2024 include TAK-960, an inhibitor of polo-like kinase, and MK-2206, an AKT inhibitor. TAK-960 has shown variable anti-proliferative responses in colorectal cancer models, and MK-2206 has demonstrated growth inhibition and reduced migration in glioblastoma and nasopharyngeal carcinoma cell lines. Both drugs are being evaluated in clinical trials and may offer new therapeutic options.

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DS-9606a for Cancer

Phase 1

Recruiting

Research Sponsored by Daiichi Sankyo, Inc.

Eligibility Criteria Checklist

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

Must have

Cohort B-1: Ovarian cancer

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

Must not have

Has a history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment

History of myocardial infarction or unstable angina within 6 months before study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests DS-9606a, a new drug, in patients with advanced solid tumors to see if it is safe and effective. Researchers want to know if it can slow tumor growth and how the body handles the drug.

Who is the study for?

Adults with advanced solid tumors, including ovarian and germ cell cancers, who are in good physical condition (ECOG score of 0 or 1) can join. They must have a life expectancy over 3 months, proper heart function, and agree to contraception. Those with brain metastases treated successfully may qualify; however, individuals with recent serious heart issues or uncontrolled infections cannot participate.

What is being tested?

The trial is testing DS-9606a's safety for patients with various advanced solid tumors. It will involve participants providing tissue samples before and during treatment to assess the drug's effects on their cancer.

What are the potential side effects?

While specific side effects of DS-9606a are not listed here, common ones for cancer treatments include fatigue, nausea, risk of infection due to low blood counts, potential allergic reactions to the drug infusion, and possible organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

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

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I have ovarian cancer.

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I am fully active or can carry out light work.

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I am 18 years old or older.

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My organs and bone marrow are functioning well.

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My cancer has worsened despite treatment, or I cannot tolerate/choose not to have standard treatment.

Exclusion Criteria

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

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I have had serious heart issues, including heart failure or irregular heartbeat needing treatment.

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I have not had a heart attack or unstable chest pain in the last 6 months.

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I have an infection that needs long-term treatment.

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I have an active or uncontrolled hepatitis B or C infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion: DS-9606aExperimental Treatment1 Intervention

Participants with ovarian cancer who will receive an intravenous (IV) dose of DS9606a at the recommended dose for expansion (RDE) every 3 weeks.

Group II: Dose Escalation: DS-9606aExperimental Treatment1 Intervention

Participants who will receive an intravenous (IV) dose of DS9606a starting at 0.016 mg/kg every 3 weeks.

0 / 9Eligibility 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 Germ Cell Tumors (GCTs) include aggressive chemotherapy and high-dose chemotherapy with stem-cell support. These treatments work by targeting rapidly dividing cancer cells, thereby reducing tumor size and preventing metastasis. Chemotherapy agents such as cisplatin, etoposide, and bleomycin are often used, which induce DNA damage and apoptosis in cancer cells. High-dose chemotherapy followed by stem-cell support helps to restore the bone marrow function after intensive treatment. The potential role of targeted therapies, which are designed to interfere with specific molecular pathways involved in tumor growth and survival, is also being explored. Understanding these mechanisms is crucial for GCT patients as it helps in selecting the most effective treatment regimen, managing side effects, and improving overall prognosis.

Central nervous system germ cell tumors: an update.