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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Qualigen Theraputics, Inc.
Study ID
NCT06086522
Phase
PHASE1
Status
Recruiting
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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QN-302 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 1, 2023
Status verified
Apr 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Cohort 1
    Starting dose in Phase 1a dose escalation
  • Other: Cohort 2
    2nd cohort in Phase 1a dose escalation

Primary Outcome Measure

Determine MTD [ Time Frame: 18 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
HonorHealthScottsdaleArizona85251
Andrew Islas
833-354-6667
[email protected]
Erkut Borazanci, MD (PRINCIPAL_INVESTIGATOR)
YaleNew HavenConnecticut06520
Patricia LoRusso, DO (PRINCIPAL_INVESTIGATOR)
START MidwestGrand RapidsMichigan49546
Abigail VanKirk
616-389-1824
Abigail VanKirk
[email protected]
616.389.1824
Sreenivasa Chandana, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77002
Jordi Rodon, MD (PRINCIPAL_INVESTIGATOR)

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HonorHealth· Scottsdale, AZYale· New Haven, CTSTART Midwest· Grand Rapids, MIMD Anderson Cancer Center· Houston, TX

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