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
Qualigen Theraputics, Inc.
Summary
Goal: learn about QN-302 in patients with solid tumors (metastatic, or advanced cancer). Main questions: * What does the study drug do to human body (Pharmacodynamics \[='PD'\]) * What does the body do to study drug (how processed in body (Pharmacokinetics \[='PK'\]) - Safety Study drug by intravenous infusion ('IV') once weekly for 3 weeks every 4-week 'cycle.' Study treatment continues as long as patient and their study doctor agree that study treatment is in the best interest of the patient.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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: \-
Interventions
- DrugQN-302
Phase 1 dose-finding study, the study design is for QN-302 to be given once a week, intravenously over 60 min, on Day 1, Day 8, and Day 15 of a 28-Day cycle.
Locations (4)
- HonorHealthScottsdale, Arizona
- YaleNew Haven, Connecticut
- START MidwestGrand Rapids, Michigan
- MD Anderson Cancer CenterHouston, Texas