Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06086522

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

HonorHealth, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

QN-302

Drug

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.

Primary outcomes

  1. Determine MTD

    Time frame: 18 months

    maximum tolerated dose identified from dose escalation cohorts

  2. Establish RP2D

    Time frame: 24 months

    recommended Phase 2 dose identified from dose escalation cohorts

Study contacts

Contact information is provided by the study sponsor or research team.

Tariq Arshad, MD

CONTACT

[email protected]

use email

Sponsors and collaborators

Lead sponsor

Qualigen Theraputics, Inc.

Industry

Collaborators

  • Translational Drug Development

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 17, 2023
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.