A Phase I Trial Evaluating Safety, PD & PK of IV Study Medication, QN-302, in Patients With Advanced or Metastatic Solid Tumors
Sponsor
Qualigen Theraputics, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06086522
Collaborator
Translational Drug Development (Other)
54
4
1
37.7
13.5
0.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
54 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Dose escalation, Dose expansionDose escalation, Dose expansion
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date
:
Oct 12, 2023
Anticipated Primary Completion Date
:
Dec 1, 2025
Anticipated Study Completion Date
:
Dec 1, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Cohort 1 Starting dose in dose escalation |
Drug: QN-302
dose escalation/dose expansion
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HonorHealth | Scottsdale | Arizona | United States | 85251 |
| 2 | Yale | New Haven | Connecticut | United States | 06520 |
| 3 | START Midwest | Grand Rapids | Michigan | United States | 49546 |
| 4 | MD Anderson Cancer Center | Houston | Texas | United States | 77002 |
Sponsors and Collaborators
- Qualigen Theraputics, Inc.
- Translational Drug Development
Investigators
- Study Director: Tariq Arschad, MD, Qualigen Theraputics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Qualigen Theraputics, Inc.
ClinicalTrials.gov Identifier:
NCT06086522
Other Study ID Numbers:
- 302P1V01
First Posted:
Oct 17, 2023
Last Update Posted:
Oct 17, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: