NCT06086522

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
7mo left

Started Nov 2023

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Nov 2023Dec 2026

First Submitted

Initial submission to the registry

October 11, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

2.1 years

First QC Date

October 11, 2023

Last Update Submit

April 30, 2024

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Cohort 1

OTHER

Starting dose in Phase 1a dose escalation

Drug: QN-302

Cohort 2

OTHER

2nd cohort in Phase 1a dose escalation

Drug: QN-302

Interventions

QN-302DRUG

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.

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

HonorHealth

Scottsdale, Arizona, 85251, United States

RECRUITING

Yale

New Haven, Connecticut, 06520, United States

NOT YET RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77002, United States

NOT YET RECRUITING

Study Officials

  • Tariq Arshad, MD

    Qualigen Theraputics, Inc.

    STUDY DIRECTOR

Central Study Contacts

Tariq Arshad, MD

CONTACT

use emailclinicaltrials@qlgntx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Dose escalation, Dose expansion
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 17, 2023

Study Start

November 1, 2023

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

May 1, 2024

Record last verified: 2024-04

Locations

US(4)