NCT06771622

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: FBD Biologics Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Solid Cancer

Interventions

Type	Name	Description
DRUG	HCB101	QW
DRUG	Trastuzumab	8 mg/kg IV loading dose on Day 1 of cycle 1, then 6 mg/kg IV every 21 days;
DRUG	Pertuzumab	840 mg IV on Day 1, cycled every 21 days;
DRUG	Oxaliplatin	130 mg/m2 IV on Day 1, cycled every 21 days
DRUG	Capecitabine	1000 mg/m2 PO BID on Days 1-14, Cycled every 21 days
DRUG	Ramucirumab	8 mg/kg IV on Days 1 and 15, Cycled every 28 days
DRUG	Paclitaxel	80 mg/m2 IV on Days 1, 8, and 15, Cycled every 28 days
DRUG	Bevacizumab	5 mg/kg IV on Day 1, Repeat every 2 weeks;
DRUG	Cetuximab	400 mg/m2 first infusion, followed by 250 mg/m2 IV weekly;
DRUG	Irinotecan	180 mg/m2 IV over 30-90 minutes on Day 1 every 2 weeks
DRUG	Leucovorin	400 mg/m2 IV on Day 1 every 2 weeks
DRUG	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
DRUG	Toripalimab	240 mg/kg IV on Day 1 Cycled every 21 days
DRUG	Albumin-bound paclitaxel	125 mg/m2 IV on day 1 and Day 8 Cycled every 21 days
DRUG	Pembrolizumab	200 mg IV day 1; given every 21 days
DRUG	Carboplatin (AUC 5)	AUC=5, IV on D1, Q3W for 4\~6 cycles
DRUG	Etoposide	100mg/m2, IV on D1, 2, 3, Q3W for 4\~6 cycles
DRUG	Atezolizumab	1200 mg IV on D1, Q3W
DRUG	Trastuzumab deruxtecan	5.4 mg/kg IV on D1, Q3W

Timeline

• Start date: 2025-03-13
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2025-01-13
• Last updated: 2026-02-04

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study