What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, immunotherapy, and targeted therapy, have a range of side effects. Chemotherapy agents like oxaliplatin can cause neuropathy, diarrhea, nausea, vomiting, and fatigue. Pemetrexed plus gemcitabine can lead to significant hematologic toxicity, including neutropenia and anemia, as well as nonhematologic toxicities like fatigue, constipation, and dehydration. Immunotherapies such as nivolumab and ipilimumab can cause immune-related adverse events, including diarrhea, rash, pneumonitis, and pruritus. These side effects vary in severity and frequency, and patient tolerance can differ based on individual health conditions and treatment regimens.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for the treatment of advanced solid tumors. Notable examples include pembrolizumab and nivolumab, which are immune checkpoint inhibitors used in various cancers such as melanoma, non-small cell lung cancer, and renal cell carcinoma. Targeted therapies like vemurafenib and dabrafenib, which inhibit the BRAF mutation, have been approved for melanoma. Additionally, combination therapies such as nivolumab with ipilimumab have shown efficacy in treating advanced solid tumors. These approvals highlight the FDA's focus on innovative treatments that target specific molecular pathways or enhance the immune response against cancer cells.

What other types of research exist?

Promising novel alternatives to VVD-130037 for solid tumor patients include: <ol> <li>Talimogene laherparepvec (T-VEC): An oncolytic virus therapy showing efficacy in melanoma and other solid tumors.</li> <li>Checkpoint inhibitors: Such as pembrolizumab and nivolumab, which have shown success in various solid tumors by enhancing the immune response against cancer cells.</li> <li>Combination therapies: Including immune checkpoint inhibitors with anti-VEGF/VEGFR agents, which are being actively investigated for their synergistic effects in solid tumors.</li> <li>Targeted therapies: Such as BRAF inhibitors (vemurafenib, dabrafenib) for tumors with specific genetic mutations.</li> <li>CAR-T cell therapies: Emerging as a potential treatment for solid tumors by modifying patients' T-cells to target cancer cells.</li> </ol>

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VVD-130037 for Advanced Cancers

Phase 1

Recruiting

Research Sponsored by Vividion Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to end of treatment (up to approximately 4 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, VVD-130037, for safety and effectiveness in patients with advanced solid tumors. It will study how the drug moves through and affects the body, and whether it can help treat these tumors.

Who is the study for?

This trial is for adults with advanced solid tumors who have tried all standard treatments without success. They must be relatively active (ECOG ≤1), have a confirmed diagnosis, measurable disease by RECIST v1.1, and good organ/marrow function. It's not for those with certain genetic mutations or unresolved severe side effects from past cancer treatments, heart issues, seizure risks, brain metastases/spinal compression, or uncontrolled high blood pressure.

What is being tested?

The study tests VVD-130037 to see its safety and how it affects the body and tumor growth in patients with advanced solid tumors. This first-in-human trial will also look at how the drug moves through and out of the body (pharmacokinetics) and what it does to the body (pharmacodynamics).

What are the potential side effects?

As this is a first-in-human study for VVD-130037, potential side effects are being evaluated; however common side effects may include reactions at injection site, fatigue, nausea or other digestive issues based on similar drugs' profiles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to end of treatment (up to approximately 4 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to end of treatment (up to approximately 4 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to end of treatment (up to approximately 4 years) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period

Secondary study objectives

QT/Corrected QT (QTc) Interval and Other Electrocardiogram (ECG) Parameters

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: VVD-130037 Dose EscalationExperimental Treatment1 Intervention

Participants will receive ascending doses of VVD-130037, orally, once daily in 21-day treatment cycles.

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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 solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular pathways crucial for tumor growth and survival, thereby minimizing damage to normal cells. Immunotherapy, including checkpoint inhibitors, enhances the body's immune response against cancer cells. Investigational drugs like VVD-130037 are designed to improve efficacy and reduce toxicity by focusing on specific molecular targets or pathways involved in tumor progression. Understanding these mechanisms is crucial for solid tumor patients as it helps in selecting the most appropriate and potentially effective treatment with manageable side effects.

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