This phase 1 study of CX-3543 is designed to test the safety, tolerability and highest safe dose level of this drug in patients with advanced solid tumor cancers.
CX-4945 is a first-in-class small-molecule targeted cancer therapeutic derived from the validated fluoroquinolone class of drugs. This drug was rationally designed to target a G-quadruplex (QPLX) DNA structure and disrupt protein-DNA interactions essential to cancer cells. The QPLX targeted by quarfloxin forms within ribosomal DNA (rDNA) and the QPLX is bound by the nucleolin protein.This Phase 1 study of CX-3543 is designed to test the safety, tolerability and highest safe dose level of this drug in patients with advanced solid tumor cancers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Escalating doses of CX-3543 administered intravenously daily for 5 consecutive days every 21 days.
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
San Antonio, Texas, United States
Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT)
Time frame: Cycle 1
Recommended Phase 2 dose
Time frame: Cycle 1
Pharmacokinetics (PK) in humans of intravenously administered CX-3543.
Time frame: Monthly
Evaluate evidence of antitumor activity of CX-3543 by objective radiographic assessment.
Time frame: Every two months
Pharmacodynamic evaluation of antitumor activity
Time frame: Monthly
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.