What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, targeted therapy, and immunotherapy, often come with a range of side effects. Chemotherapy can cause myelosuppression, alopecia, mucosal inflammation, nausea, and fatigue. Targeted therapies, which include tyrosine kinase inhibitors, may lead to hypertension, hypothyroidism, diarrhea, and skin rashes. Immunotherapies, such as checkpoint inhibitors, can result in immune-related adverse events like pneumonitis, colitis, hepatitis, and endocrinopathies. These side effects vary in severity and frequency depending on the specific drug and patient characteristics.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors, particularly those with novel or investigational mechanisms of action. Examples include tyrosine kinase inhibitors like cabozantinib (approved for medullary thyroid cancer and renal cell carcinoma) and immunotherapies such as nivolumab and pembrolizumab, which target PD-1/PD-L1 pathways and are used in various cancers including melanoma and non-small cell lung cancer. Additionally, drugs like eribulin, a microtubule dynamics inhibitor, have been approved for advanced liposarcoma and leiomyosarcoma. These approvals highlight the FDA's commitment to advancing treatments for solid tumors through innovative and targeted therapeutic approaches.

What other types of research exist?

Promising novel alternatives to QN-302 for solid tumor patients include: <ol> <li>Nivolumab: An immune checkpoint inhibitor that has shown efficacy in various solid tumors, including non-small cell lung cancer and renal cell carcinoma.</li> <li>Pembrolizumab: Another immune checkpoint inhibitor effective in multiple solid tumors, particularly those expressing PD-L1.</li> <li>Atezolizumab: An anti-PD-L1 antibody used in combination with other therapies for enhanced efficacy in solid tumors like renal cell carcinoma.</li> <li>Cabozantinib: A tyrosine kinase inhibitor effective in medullary thyroid cancer and renal cell carcinoma.</li> <li>Lutetium Lu 177 vipivotide tetraxetan: A radioligand therapy showing promise in prostate cancer and potentially other solid tumors. These alternatives have demonstrated significant clinical benefits and are likely to be important treatment options in 2024.</li> </ol>

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QN-302 for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Qualigen Theraputics, Inc.

Eligibility Criteria Checklist

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

Must have

Patients with histologically confirmed locally advanced or metastatic solid carcinomas, who have had tumor progression after receiving all standard of care therapies or for which there is no approved therapy

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called QN-302 in patients with advanced or metastatic solid tumors. The drug is given through an IV on a regular schedule. Researchers want to learn how the drug affects the body and how the body processes it, while also ensuring it is safe for patients.

Who is the study for?

This trial is for patients with advanced or metastatic solid tumors who have seen their cancer progress after all standard treatments, or when no approved therapy exists. They must have a disease that can be measured by RECIST 1.1 criteria.

What is being tested?

The trial is testing QN-302, a new drug given through an IV once a week for three weeks in every four-week cycle. It aims to understand the drug's effects on the body (PD) and how the body processes it (PK), as well as its safety.

What are the potential side effects?

While specific side effects of QN-302 are not listed, common ones for cancer drugs include fatigue, nausea, infusion reactions, organ inflammation, blood disorders and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer has spread and worsened after all standard treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

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

Determine MTD

Establish RP2D

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: Cohort 2Experimental Treatment1 Intervention

2nd cohort in Phase 1a dose escalation

Group II: Cohort 1Experimental Treatment1 Intervention

Starting dose in Phase 1a dose escalation

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

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 healthy 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. Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment, managing expectations regarding efficacy and side effects, and exploring new investigational drugs like QN-302, which may offer novel mechanisms of action and potentially improved outcomes.

Recent advances in systemic therapy of soft tissue sarcomas.