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Trial Title:
Trial to Evaluate Safety, PD & PK of IV Study Drug, QN-302, in Pts w/ Advanced or Metastatic Solid Tumors
NCT ID:
NCT06086522
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Intervention model description:
Dose escalation, Dose expansion
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QN-302
Description:
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.
Arm group label:
Cohort 1
Arm group label:
Cohort 2
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.
Criteria for eligibility:
Criteria:
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:
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HonorHealth
Address:
City:
Scottsdale
Zip:
85251
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrew Islas
Phone:
833-354-6667
Contact backup:
Email:
anislas@honorhealth.com
Investigator:
Last name:
Erkut Borazanci, MD
Email:
Principal Investigator
Facility:
Name:
Yale
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Patricia LoRusso, DO
Email:
Principal Investigator
Facility:
Name:
START Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Contact:
Last name:
Abigail VanKirk
Phone:
616-389-1824
Contact backup:
Last name:
Abigail VanKirk
Phone:
616.389.1824
Email:
abigail.vankirk@startmidwest.com
Investigator:
Last name:
Sreenivasa Chandana, MD
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77002
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Jordi Rodon, MD
Email:
Principal Investigator
Start date:
November 1, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Qualigen Theraputics, Inc.
Agency class:
Industry
Collaborator:
Agency:
Translational Drug Development
Agency class:
Other
Source:
Qualigen Theraputics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06086522
