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.

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

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Tariq Arshad, MD

Principal Investigator

Qualigen Theraputics, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+