drugset
drugset / Trial / NCT06771622

Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors

NCT06771622 ↗

Phase 1/2 Active not recruiting 500 enrolled FBD Biologics Limited
Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2025-03-13
Primary completion
2028-01-01
Completion
2029-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject HCB101 Protein / enzyme biologic — —
Background Atezolizumab Monoclonal antibody 1200 mg Intravenous
Background Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Carboplatin Small molecule 5 unknown Intravenous
Background Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Background Etoposide Small molecule 100 mg/m2 Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous
Background Paclitaxel Small molecule 125 mg/m2 Intravenous
Background Pembrolizumab Monoclonal antibody 200 mg Intravenous
Background Pertuzumab Monoclonal antibody 840 mg Intravenous
Background Ramucirumab Monoclonal antibody 8 mg/kg Intravenous
Background Toripalimab Monoclonal antibody 240 mg/kg Intravenous
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Background Trastuzumab deruxtecan Monoclonal antibody 5.4 mg/kg Intravenous
Background fluorouracil Small molecule 1200 mg/m2 Intravenous

Indications

No indication recorded.