NCT06086522

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Qualigen Theraputics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	QN-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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2023-10-17
• Last updated: 2024-05-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study