This is a non-randomized, open-label, dose-escalation, and dose-expansion Phase Ib/IIa study to evaluate the safety, tolerability, PK, PD, and preliminary antitumor activity of HCB101 administered in combination with standard or approved anticancer therapies in subjects with advanced solid tumors. The trial includes a Part-I (Phase Ib) of the dose-escalation phase and a Part-II (Phase IIa) of the dose-expansion phase. Part-I: Dose-escalation phase (Phase Ib): Part I uses a standard 3+3 dose-escalation design to characterize safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of HCB101 when administered in combination regimens. The study includes 14 planned cohorts (Cohorts 1-9, including sub-cohorts 3a-3d and 6a-6c). Part-II: Dose-expansion phase (Phase IIa) Based on safety, tolerability, PK/PD, and emerging antitumor activity observed in Part-I (Phase Ib), selected dose levels, tumor types, and combination regimens will be further investigated in Part-II (Phase IIa).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
QW
8 mg/kg IV loading dose on Day 1 of cycle 1, then 6 mg/kg IV every 21 days;
840 mg IV on Day 1, cycled every 21 days;
130 mg/m2 IV on Day 1, cycled every 21 days
1000 mg/m2 PO BID on Days 1-14, Cycled every 21 days
8 mg/kg IV on Days 1 and 15, Cycled every 28 days
80 mg/m2 IV on Days 1, 8, and 15, Cycled every 28 days
5 mg/kg IV on Day 1, Repeat every 2 weeks;
400 mg/m2 first infusion, followed by 250 mg/m2 IV weekly;
180 mg/m2 IV over 30-90 minutes on Day 1 every 2 weeks
400 mg/m2 IV on Day 1 every 2 weeks
400 mg/ m2 IV bolus on Day 1, followed by 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks
240 mg/kg IV on Day 1 Cycled every 21 days
125 mg/m2 IV on day 1 and Day 8 Cycled every 21 days
200 mg IV day 1; given every 21 days
AUC=5, IV on D1, Q3W for 4\~6 cycles
100mg/m2, IV on D1, 2, 3, Q3W for 4\~6 cycles
1200 mg IV on D1, Q3W
5.4 mg/kg IV on D1, Q3W
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Number/incidence and percentage of subjects with adverse events.
To evaluate the safety and tolerability of HCB101
Time frame: 12 months
Number of subjects with Maximal tolerance dose (MTD) of HCB101
To evaluate the tolerability of HCB101
Time frame: 12 months
Overall Rate Response (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)
Time frame: 12 months
Duration of Response (DoR)
DOR is defined as time from date of initial documentation of a response (PR or CR) to date of first documented evidence of progressive disease (PD)
Time frame: 12 months
Disease Control Rate (DCR)
DCR is defined as the proportion of participants who have a partial response (PR), critical response (CR), or disease stable (SD)
Time frame: 12 months
Progression-Free Survival (PFS)
Defined as the duration from the start of treatment until tumor progression or death of any cause.
Time frame: 12 months
Peak Plasma Concentration (Cmax) of HCB101
Peak Plasma Concentration (Cmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.
Time frame: 12 months
Area under the plasma concentration versus time curve (AUC) of HCB101
Area under the plasma concentration versus time curve (AUC) of HCB101
Time frame: 12 months
Time to maximum drug concentration in plasma (Tmax) of HCB101
Time to maximum drug concentration in plasma (Tmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.
Time frame: 12 months
Terminal elimination half-life (t1/2) of HCB101
Terminal elimination half-life (t1/2) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.