This is a Phase 1, nonrandomized, open-label, dose-escalation study of 3-hour IV infusions of RH-1 administered to patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL). Treatment will continue until a patient meets criteria for discontinuation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
1.5 mg/m2 to 12 mg/m2, depending on protocol cohort, administered via intravenous (IV) infusion over 3 hours once every 21 days.
University of Colorado Health Science Center
Aurora, Colorado, United States
Hudson-Webber Cancer Research Center
Detroit, Michigan, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Cancer Therapy & Research Center
San Antonio, Texas, United States
To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of a 3-hour intravenous (IV) infusion of RH-1 administered once every 21 days.
Time frame: Study duration
To evaluate the safety and tolerability of 3-hour IV infusions of RH-1.
Time frame: Study duration
To determine the pharmacokinetic (PK) profile of 3-hour IV infusions of RH-1 administered at escalating doses.
Time frame: Study duration
To assess preliminary evidence of anti-cancer activity of RH-1.
Time frame: Study duration
To explore evidence of differential deoxyribonucleic acid (DNA) cross-linking and downstream phenotypic consequences of RH-1 exposure in peripheral blood mononuclear cells (PBMCs), circulating tumor cells (CTCs), and tumor biopsies.
Time frame: Study duration
To explore the correlation and possible significance of germline polymorphisms in NAD(P)H:quinone oxidoreductase (NQO1) and DNA cross-linking as consequences of RH-1 exposure in PBMCs, CTCs, and tumor biopsies, as markers of anticancer activity.
Time frame: Study duration
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