DBC-664-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamic, and preliminary anti-tumor activity of DBC-664 in patients with endometrial cancer, ovarian cancer, and other advanced solid tumors . This study is divided into 2 parts: Phase-1a Dose Escalation (Part 1), and Phase-1b Dose Expansion (Part 2). In each part, patients who meet specific eligibility criteria will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
DBC-664 will be administered intravenously.
Sarah Cannon Research Institute - Denver HealthONE
Denver, Colorado, United States
RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
RECRUITINGSTART New Jersey
East Brunswick, New Jersey, United States
RECRUITINGSTART New York
Lake Success, New York, United States
RECRUITINGSCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGSafety and Tolerability
The safety and tolerability of DBC-664 in patients with solid tumor measured by frequency and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), adverse events of special interest (AESIs), adverse events (AEs) leading to dose interruption and of adverse events (AEs) leading to treatment discontinuation
Time frame: 2 years
Determine Recommended Dose for Expansion
To determine the maximum tolerated dose (MTD) and/or select the recommended dose(s) for expansion (RDE\[s\]) of DBC-664
Time frame: 1 year
Characterize Pharmacokinetics
To characterize the pharmacokinetics (PK) of DBC-664 with Cmax following administration
Time frame: 2 years
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