Evaluating a new drug for patients with advanced solid tumors
A Phase I, Multicenter, Open-label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacodynamics, and Pharmacokinetics of Intravenous QN-302 in Patients With Advanced or Metastatic Solid Tumors
This study is testing a new drug called QN-302 to see if it can help people with advanced solid tumors who have run out of other treatment options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qualigen Theraputics, Inc. Industry-sponsored |
| Locations | 4 sites (Scottsdale, Arizona and 3 other locations) |
| Trial ID | NCT06086522 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety, pharmacodynamics, and pharmacokinetics of an intravenous drug called QN-302 in patients with advanced or metastatic solid tumors. Participants will receive the drug once weekly for three weeks in a four-week cycle, with treatment continuing as long as it is deemed beneficial by both the patient and their doctor. The study focuses on understanding how the drug affects the body and how the body processes the drug, particularly in patients who have exhausted standard treatment options.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with histologically confirmed locally advanced or metastatic solid carcinomas who have experienced tumor progression after standard therapies.
Not a fit: Patients with solid tumors that have not progressed after standard treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited alternatives.
How similar studies have performed: While this approach is being explored in this specific context, similar studies evaluating new treatments for advanced solid tumors have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: \-
Where this trial is running
Scottsdale, Arizona and 3 other locations
- HonorHealth — Scottsdale, Arizona, United States (Recruiting)
- Yale — New Haven, Connecticut, United States (Not_yet_recruiting)
- START Midwest — Grand Rapids, Michigan, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Tariq Arshad, MD
- Email: clinicaltrials@qlgntx.com
- Phone: use email
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.