Trial to Evaluate Safety, PD & PK of IV Study Drug, QN-302, in Pts w/ Advanced or Metastatic Solid Tumors
NCT06086522 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2024-05-01
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
Interventions
- 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.
Sponsors & Collaborators
-
Translational Drug Development
collaborator OTHER -
Qualigen Theraputics, Inc.
lead INDUSTRY
Principal Investigators
-
Tariq Arshad, MD · Qualigen Theraputics, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-01
- Primary Completion
- 2025-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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