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

Purpose

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.

Condition

  • Solid Tumor

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Dose escalation, Dose expansion
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Cohort 1 		Starting dose in Phase 1a dose escalation
  • 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.
Other
Cohort 2 		2nd cohort in Phase 1a dose escalation
  • 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.

Recruiting Locations

HonorHealth
Scottsdale, Arizona 85251
Contact:
Andrew Islas
833-354-6667

START Midwest
Grand Rapids, Michigan 49546
Contact:
Abigail VanKirk
616-389-1824

More Details

Status
Recruiting
Sponsor
Qualigen Theraputics, Inc.

Study Contact

Tariq Arshad, MD
use email
clinicaltrials@qlgntx.com