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

Phase 1

Recruiting

• Conditions: Solid Tumor
• Interventions: Drug: QN-302

• Registration Number: NCT06086522
• Lead Sponsor: Qualigen Theraputics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-17
• Study Start: 2023-11-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	QN-302	Starting dose in Phase 1a dose escalation
Cohort 2	QN-302	2nd cohort in Phase 1a dose escalation

Primary Outcome Measures

Name	Time	Method
Determine MTD	18 months	maximum tolerated dose identified from dose escalation cohorts
Establish RP2D	24 months	recommended Phase 2 dose identified from dose escalation cohorts

Trial Locations

Locations (4)

START Midwest; 🇺🇸 Grand Rapids, Michigan, United States

Yale; 🇺🇸 New Haven, Connecticut, United States

HonorHealth; 🇺🇸 Scottsdale, Arizona, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States