RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-11-01
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06086522

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Tariq Arshad, MD
CONTACT
use email
clinicaltrials@qlgntx.com

Principal Investigator

Tariq Arshad, MD
STUDY_DIRECTOR
Qualigen Theraputics, Inc.

Study Locations (Sites)

HonorHealth
Scottsdale, Arizona, 85251
United States
Yale
New Haven, Connecticut, 06520
United States
START Midwest
Grand Rapids, Michigan, 49546
United States
MD Anderson Cancer Center
Houston, Texas, 77002
United States

Collaborators and Investigators

Sponsor: Qualigen Theraputics, Inc.

  • Tariq Arshad, MD, STUDY_DIRECTOR, Qualigen Theraputics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-11-01
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumor