Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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).
Eligibility
Primary outcome measure(s)
- Number/incidence and percentage of subjects with adverse events. — 12 months
To evaluate the safety and tolerability of HCB101 - Number of subjects with Maximal tolerance dose (MTD) of HCB101 — 12 months
To evaluate the tolerability of HCB101
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Cancer Hospital of Shandong First Medical University | Jinan | Shandong |
On this site
📄 Herceptin (trastuzumab) drug profile → 📄 Avastin (bevacizumab) drug profile → 📄 Keytruda (pembrolizumab) drug profile → 📄 Tecentriq (atezolizumab) drug profile → 📄 Enhertu (trastuzumab deruxtecan) drug profile →More FBD Biologics Limited trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06771622 on ClinicalTrials.gov ↗ ← All trials in China