Trial to Evaluate Safety, PD & PK of IV Study Drug, QN-302, in Pts w/ Advanced or Metastatic Solid Tumors
NCT ID: NCT06086522
Last Updated: 2024-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
54 participants
INTERVENTIONAL
2023-11-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
Starting dose in Phase 1a dose escalation
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.
Cohort 2
2nd cohort in Phase 1a dose escalation
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Translational Drug Development
OTHER
Qualigen Theraputics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tariq Arshad, MD
Role: STUDY_DIRECTOR
Qualigen Theraputics, Inc.
Locations
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HonorHealth
Scottsdale, Arizona, United States
Yale
New Haven, Connecticut, United States
START Midwest
Grand Rapids, Michigan, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Andrew Islas
Role: primary
Role: backup
Abigail VanKirk
Role: primary
Other Identifiers
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302P1V01
Identifier Type: -
Identifier Source: org_study_id
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