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Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors
Sponsor: FBD Biologics Limited
Summary
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).
Official title: Phase Ib/IIa, Open-label, Multicenter, Dose Escalation, and Dose Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of HCB101 in Combination With Multiple Agents in Subjects With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2025-03-13
Completion Date
2029-01-01
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
HCB101
QW
Trastuzumab
8 mg/kg IV loading dose on Day 1 of cycle 1, then 6 mg/kg IV every 21 days;
Pertuzumab
840 mg IV on Day 1, cycled every 21 days;
Oxaliplatin
130 mg/m2 IV on Day 1, cycled every 21 days
Capecitabine
1000 mg/m2 PO BID on Days 1-14, Cycled every 21 days
Ramucirumab
8 mg/kg IV on Days 1 and 15, Cycled every 28 days
Paclitaxel
80 mg/m2 IV on Days 1, 8, and 15, Cycled every 28 days
Bevacizumab
5 mg/kg IV on Day 1, Repeat every 2 weeks;
Cetuximab
400 mg/m2 first infusion, followed by 250 mg/m2 IV weekly;
Irinotecan
180 mg/m2 IV over 30-90 minutes on Day 1 every 2 weeks
Leucovorin
400 mg/m2 IV on Day 1 every 2 weeks
5-FU
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
Toripalimab
240 mg/kg IV on Day 1 Cycled every 21 days
Albumin-bound paclitaxel
125 mg/m2 IV on day 1 and Day 8 Cycled every 21 days
Pembrolizumab
200 mg IV day 1; given every 21 days
Carboplatin (AUC 5)
AUC=5, IV on D1, Q3W for 4\~6 cycles
Etoposide
100mg/m2, IV on D1, 2, 3, Q3W for 4\~6 cycles
Atezolizumab
1200 mg IV on D1, Q3W
Trastuzumab deruxtecan
5.4 mg/kg IV on D1, Q3W
Locations (1)
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China