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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086522
• Other study ID #: 302P1V01
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2023
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Qualigen Theraputics, Inc.
• Contact: Tariq Arshad, MD
• Phone: use email
• Email: clinicaltrials[@]qlgntx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

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.

Locations

Country	Name	City	State
United States	START Midwest	Grand Rapids	Michigan
United States	MD Anderson Cancer Center	Houston	Texas
United States	Yale	New Haven	Connecticut
United States	HonorHealth	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Qualigen Theraputics, Inc.	Translational Drug Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine MTD	maximum tolerated dose identified from dose escalation cohorts	18 months
Primary	Establish RP2D	recommended Phase 2 dose identified from dose escalation cohorts	24 months