Recruiting
Phase 1

QN-302

Sponsor:

Qualigen Theraputics, Inc.

Code:

NCT06086522

Conditions

Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

QN-302

Study Details

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.

Conditions

Solid Tumor

Study ID

NCT06086522

Start date

Nov 1, 2023

Status verified date

Apr, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

54 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Cohort 1

Starting dose in Phase 1a dose escalation

other: Cohort 2

2nd cohort in Phase 1a dose escalation

Interventions

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.

Primary outcome measure

  • Determine MTD [ Time Frame: 18 months ]
  • Establish RP2D [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Tariq Arshad, MD

use emailclinicaltrials@qlgntx.com

Locations

HonorHealth

Recruiting

Scottsdale, Arizona, United States, 85251

Contacts

Andrew Islas

833-354-6667

anislas@honorhealth.com

Principal Investigator:

Erkut Borazanci, MD

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Abigail VanKirk

616-389-1824

Abigail VanKirk

616.389.1824abigail.vankirk@startmidwest.com

Principal Investigator:

Sreenivasa Chandana, MD

More Information

Sponsor

Qualigen Theraputics, Inc.

Last update posted

May 1, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Qualigen Theraputics, Inc. on 2024-05-01.