Solid Tumor
Conditions
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.
Interventions
DRUGQN-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.
Sponsors
Translational Drug Development
Qualigen Theraputics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose escalation, Dose expansion
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactTariq Arshad, MD
Outcome results
None listed