This is a study of DP303c in patients with HER2-positive advanced solid tumors.
This is a multi-center, single-arm Phase I study to evaluate the pharmacokinetic profile, safety, and initial efficacy of DP303c in patients with HER2-positive advanced solid tumors. Patients will be treated with DP303c injection at 3.0 mg/kg every 3 weeks. Patients will receive DP303c until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
DP303c injection, 3.0 mg/kg, every 3 weeks.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGMaximum Plasma Concentration [Cmax]
Time frame: Day 1,2,3,8, and 15 of cycle 1 and 3, and day 1 of each following cycle (each cycle is 21 days)
Area Under Curve from 0 to the last point (AUC0-last)
Time frame: Day 1,2,3,8, and 15 of cycle 1 and 3, and day 1 of each following cycle (each cycle is 21 days)
Area Under Curve from t 0 to the infinity (AUC0-inf)
Time frame: Day 1,2,3,8, and 15 of cycle 1 and 3, and day 1 of each following cycle (each cycle is 21 days)
Time to Reach Peak Serum Concentration (Tmax)
Time frame: Day 1,2,3,8, and 15 of cycle 1 and 3, and day 1 of each following cycle (each cycle is 21 days)
Incidence of adverse events (AEs)
Time frame: Up to approximately 12 months
Objective Response Rate (ORR)
Time frame: Up to approximately 12 months
Duration of Response (DoR)
Time frame: Up to approximately 12 months
Disease control rate (DCR)
Time frame: Up to approximately 12 months
Incidence of anti-drug antibodies (ADA)
Time frame: Day 1, 8, and 15 of cycle 1, and day 1 of each following cycle (each cycle is 21 days)
Incidence of Neutralizing antibodies (Nab)
Time frame: Day 1, 8, and 15 of cycle 1, and day 1 of each following cycle (each cycle is 21 days)
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