What side effects are associated with this type of intervention?

Common treatments for breast cancer include endocrine therapies like tamoxifen and aromatase inhibitors, as well as chemotherapeutic agents such as doxorubicin and paclitaxel. Tamoxifen can cause hot flashes, increased risk of thromboembolic events, and endometrial cancer. Aromatase inhibitors are associated with bone density loss, fractures, and cardiovascular risks. Chemotherapeutic agents like doxorubicin can lead to cardiotoxicity, while paclitaxel is known for causing peripheral neuropathy and myelosuppression. Trastuzumab, another common treatment, can also cause cardiotoxicity, especially in patients previously treated with anthracyclines.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer include a variety of targeted therapies and chemotherapeutic agents. Notable examples include trastuzumab (Herceptin), which targets the HER2 receptor, and palbociclib (Ibrance), a CDK4/6 inhibitor used in combination with hormone therapy for HR-positive, HER2-negative breast cancer. Additionally, PARP inhibitors like olaparib (Lynparza) are approved for BRCA-mutated breast cancer. These treatments, similar to the investigational drug VIO-01, often focus on specific molecular targets or are used in combination with other therapies to enhance efficacy and manage disease progression.

What other types of research exist?

Promising novel alternatives to VIO-01 for breast cancer patients in 2024 include: 1) The combination of metronomic vinorelbine and capecitabine (mVNR and mCAPE), which has shown high activity and good tolerability in hormone receptor-positive/HER2-negative breast cancer patients. 2) PARP inhibitors like olaparib and niraparib, which are effective in patients with BRCA mutations. 3) Immunotherapies such as pembrolizumab, which has shown efficacy in metastatic breast cancer. These alternatives have demonstrated promising results in recent clinical trials and could be considered for treatment in 2024.

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VIO-01 for Recurrent Cancer

Phase 1 & 2

Recruiting

Led By Alexander Philipovskiy, M.D., PhD

Research Sponsored by Valerio Therapeutics

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Participants with neurologic disorders such as Guillain-Barré syndrome (GBS), myasthenia gravis (MG), Parkinson's disease, amyotrophic lateral sclerosis (ALS), seizure disorder, multiple sclerosis (MS), or other chronic neurologic condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called VIO-01 to see if it can help treat certain types of advanced cancers with specific genetic mutations. The study will check how safe the drug is, how well the body absorbs it, and its effects on the tumors.

Who is the study for?

This trial is for people with recurrent solid tumors, including specific types like prostate, ovarian, and breast cancers. Participants should have previously tried standard treatments without success. The study will also focus on individuals with advanced HRRm or HRD+ solid tumors and those with the same conditions in recurrent ovarian cancer.

What is being tested?

The trial is testing VIO-01's safety when used alone or alongside other anti-cancer therapies. It consists of two parts: determining the maximum safe dose and how well patients tolerate it (Part 1), followed by assessing its effectiveness in advanced HRRm/HRD+ solid tumors (Part 2).

What are the potential side effects?

While not specified here, typical side effects from new cancer drugs can include nausea, fatigue, skin reactions, blood count changes leading to increased infection risk or bleeding problems, and potential allergic reactions.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have a chronic neurological condition like MS or Parkinson's.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 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

Phase 1: Dose Limiting Toxicities

Phase 2: Objective Response Rate (ORR)

Secondary study objectives

Phase 1: Assess the pharmacokinetics (PK) of VIO-01

Phase 2: Duration of response (DOR)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Expansion HRRm or HRD+ Solid TumorsExperimental Treatment1 Intervention

Participants with advanced HRRm or HRD+ solid tumors will be administered recommended Phase 2 dose of VIO-01 via intravenous infusion over a 60-minute period once weekly.

Group II: Dose Expansion HRRm or HRD+ Ovarian CancerExperimental Treatment1 Intervention

Participants with advanced HRRm or HRD+ ovarian cancer will be administered recommended Phase 2 dose of VIO-01via intravenous infusion over a 60-minute period once weekly.

Group III: Dose EscalationExperimental Treatment1 Intervention

Dose escalation: Multiple dose levels of VIO-01 will be administered via intravenous infusion over a 60-minute period once weekly.

0 / 1Eligibility 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 breast cancer include targeted therapies, hormone therapies, and chemotherapy. Targeted therapies, such as trastuzumab and T-DM1, work by specifically targeting HER2-positive cancer cells, thereby inhibiting their growth and survival. Hormone therapies, like tamoxifen and aromatase inhibitors, block hormone receptors or reduce hormone production, which is crucial for hormone receptor-positive breast cancers. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. These treatments are essential as they offer personalized and effective options to manage and potentially eradicate breast cancer, improving survival rates and quality of life for patients.

Challenges in the diagnosis and management of cervical neuroendocrine carcinoma.Promising novel therapies for the treatment of endometrial cancer.New drugs for breast cancer.