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QN-302 for Advanced or Metastatic Solid Tumors

This study is looking at a drug called QN-302 for people with advanced or metastatic (spread to other parts of the body) solid tumors. The main goals are to understand how QN-302 affects the body (pharmacodynamics or 'PD'), how the body processes the drug (pharmacokinetics or 'PK'), and to check its safety. QN-302 is given through an IV (intravenous infusion) once a week for three weeks, followed by a week off, making a 28-day cycle. You can join if your cancer has progressed after standard treatments or if there are no approved treatments for your condition. The study aims to find the highest safe dose (MTD) and the recommended dose for future studies (RP2D). Treatment continues as long as you and your doctor agree it's beneficial.

Study design
This is an interventional study with a planned enrollment of 54 participants. It is a dose-finding study, meaning different doses of QN-302 will be tested.
What's involved
Participants will receive QN-302 intravenously once a week for three weeks, followed by a one-week break, in 28-day cycles. Treatment continues as long as it is in the patient's best interest.
Compensation
Not stated in the trial record.
Follow-up
The study aims to determine the MTD at 18 months and the RP2D at 24 months, suggesting follow-up will occur for at least this long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06086522

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Qualigen Theraputics, Inc.
~54 participants
Updated 2024-05-01 on ClinicalTrials.gov
What's tested:QN-302

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine MTD
Measured over 18 months
+1 more outcome measured

Conditions

Solid Tumor

Explore related trials

Solid Neoplasm

NCT06086522

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • HonorHealth

    Scottsdale, Arizonastudy coordinator listed

    Recruiting

  • START Midwest

    Grand Rapids, Michiganstudy coordinator listed

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasno site contact published

    Not yet recruiting

  • Yale

    New Haven, Connecticutno site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tariq Arshad, MD · STUDY_DIRECTOR · Qualigen Theraputics, Inc.

Who to contact

Tariq Arshad, MD
[email protected]
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Eligibility criteria

Inclusion

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 2. Evaluable or measurable disease by RECIST 1.1

What this trial measures

  • Determine MTD18 months

    maximum tolerated dose identified from dose escalation cohorts

  • Establish RP2D24 months

    recommended Phase 2 dose identified from dose escalation cohorts