QN-302 for Advanced Cancer

Recruiting at 3 trial locations

Overseen By Drew Hertig

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Qualigen Theraputics, Inc.

Disqualifiers: Diabetes, Hypertension, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Variable (as long as beneficial)

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called QN-302 for individuals with advanced or metastatic solid tumors—cancers that have spread and no longer respond to standard treatments. The trial aims to understand how QN-302 behaves in the body and how the body processes it, while also monitoring for any side effects. Participants will receive the treatment through an IV once a week for three weeks, followed by a break in the fourth week, and can continue if it proves beneficial. The trial seeks individuals with confirmed advanced cancers that have progressed despite all other treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctor to understand how your current medications might interact with the study drug.

Is there any evidence suggesting that QN-302 is likely to be safe for humans?

Studies have shown that QN-302, a new treatment for advanced cancer, has promising effects against tumors. In earlier research, QN-302 slowed or stopped the growth of cancer cells.

Regarding safety, early clinical trials are testing QN-302. This phase focuses on determining the treatment's safety for people and how the body processes it. Researchers closely monitor patients for any side effects or reactions. Although detailed safety information from these trials isn't available yet, reaching this stage suggests initial results were promising enough to continue.

The treatment is administered through an IV (intravenous infusion) once a week for three weeks in a four-week cycle. This schedule allows doctors and researchers to assess how well patients tolerate the treatment over time.

In summary, while QN-302 has shown potential in early studies, its safety is still under careful evaluation in current trials. Researchers will closely monitor participants to ensure the best possible outcome. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced cancer, which often involve chemotherapy or targeted therapies acting on specific proteins, QN-302 works differently by targeting a new mechanism. Researchers are excited about QN-302 because it offers a novel approach by potentially interacting with genetic markers associated with cancer progression, which might enhance its effectiveness across various cancer types. This innovative mechanism could lead to more personalized treatment options and fewer side effects, making it a promising candidate in the fight against advanced cancer.

What evidence suggests that QN-302 might be an effective treatment for advanced cancer?

Research has shown that QN-302, the investigational treatment in this trial, could be promising for advanced cancers. Studies have found that QN-302 attaches to specific parts of DNA in cancer cells, known as G-quadruplexes. This attachment can disrupt the cancer cells' ability to grow and multiply. In tests with mice, QN-302 effectively shrank tumors and was well tolerated. Additionally, QN-302 reduced levels of certain proteins linked to cancer growth, such as the S100P protein. These early findings suggest that QN-302 could benefit people with advanced solid tumors. ^{2 3 4 6 7}

Who Is on the Research Team?

Tariq Arshad, MD

Principal Investigator

Qualigen Theraputics, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Evaluable or measurable disease by RECIST 1.1

My cancer has spread and worsened after all standard treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study drug QN-302 by intravenous infusion once weekly for 3 weeks every 4-week cycle. Treatment continues as long as it is in the best interest of the patient.

Variable (as long as beneficial)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Dose Escalation

Determine maximum tolerated dose (MTD) and establish recommended Phase 2 dose (RP2D) through dose escalation cohorts

18-24 months

What Are the Treatments Tested in This Trial?

Interventions

• QN-302

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 1 Intervention

2nd cohort in Phase 1a dose escalation

Group II: Cohort 1 Experimental Treatment 1 Intervention

Starting dose in Phase 1a dose escalation

QN-302 is already approved in United States for the following indications:

Approved in United States as QN-302 for:

• Orphan Drug Designation for pancreatic cancer

Who Is Running the Clinical Trial?

Qualigen Theraputics, Inc.

Lead Sponsor

Trials

1

Recruited

50+

Translational Drug Development

Collaborator

Trials

19

Recruited

1,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10051992/

The Potent G-Quadruplex-Binding Compound QN-302 ... We show here that QN-302 also causes downregulation of the expression of the S100P gene and the S100P protein in cells and in vivo.

2. academic.oup.com academic.oup.com/nar/article/53/4/gkaf085/8010959

G-quadruplex experimental drug QN-302 impairs liposarcoma ... In patient-derived xenograft mouse models, QN-302 treatment reduced tumour volume distribution and was well tolerated. We have identified a ...

3. aacrjournals.org aacrjournals.org/cancerres/article/84/6_Supplement/576/740070/Abstract-576-The-pan-quadruplex-drug-QN-302

Abstract 576: The pan-quadruplex drug QN-302 selectively ... RNA-seq whole-genome transcriptome analysis revealed that QN-302 selectively targets G-quadruplexes in cancer-related genes, notably by forming ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06086522

Trial to Evaluate Safety, PD & PK of IV Study Drug, QN-302 ... Trial to Evaluate Safety, PD & PK of IV Study Drug, QN-302, in Pts w/​ Advanced or Metastatic Solid Tumors. ClinicalTrials.gov ID NCT06086522.

5. nature.com nature.com/articles/s41598-024-54080-2

Structure–activity relationships for the G-quadruplex ... QN-302 is significantly more potent than the two analogues in a panel of pancreatic cancer cell lines. Dynamics simulations as well as ...

6. qlgntx.com qlgntx.com/pipeline/qn-302/

QN-302 Data further demonstrated that QN-302 had significant anti-tumor activity in three patient-derived PDAC patient-derived xenograft models. Early safety ...

7. clin.larvol.com clin.larvol.com/trial-detail/NCT06086522

Trial to Evaluate Safety, PD & PK of IV Study Drug, QN-302 ... The first patient in the Phase 1a clinical trial has been dosed with QN-302 designed for the treatment of advanced or metastatic solid tumors.