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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: QN-302

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Tariq Arshad, MD; Phone Number: use email; Email: clinicaltrials@qlgntx.com
• Study Contact Backup: Name: Drew Hertig; Phone Number: use email; Email: clinicaltrials@qlgntx.com

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Recruiting
      • HonorHealth
      • Principal Investigator: Erkut Borazanci, MD
      • Contact: Andrew Islas; Phone Number: 833-354-6667
      • Contact: Email: anislas@honorhealth.com
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Not yet recruiting
      • Yale
      • Principal Investigator: Patricia LoRusso, DO
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • Start Midwest
      • Principal Investigator: Sreenivasa Chandana, MD
      • Contact: Abigail VanKirk; Phone Number: 616-389-1824
      • Contact: Abigail VanKirk; Phone Number: 616.389.1824; Email: abigail.vankirk@startmidwest.com
  • Texas
    • Houston, Texas, United States, 77002
      • Not yet recruiting
      • MD Anderson Cancer Center
      • Principal Investigator: Jordi Rodon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort 1; Starting dose in dose escalation	Drug: QN-302; dose escalation/dose expansion; Other Names: dose escalation cohorts
Other: Cohort 2; 2nd cohort in dose escalation	Drug: QN-302; dose escalation/dose expansion; Other Names: dose escalation cohorts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine MTD	maximum tolerated dose identified from dose escalation cohorts	18 months
Establish RP2D	recommended Phase 2 dose identified from dose escalation cohorts	24 months

Collaborators and Investigators

• Sponsor: Qualigen Theraputics, Inc.
• Collaborators: Translational Drug Development
• Investigators: Study Director: Tariq Arshad, MD, Qualigen Theraputics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 302P1V01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No