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

Sponsor
FBD Biologics Limited
Study ID
NCT06771622
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Solid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Mar 13, 2025
Status verified
Apr 2025
Primary completion
Jan 1, 2028
Completion
Jan 1, 2029

Study Design

Enrollment
500 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: HCB101+Trastuzumab+Pertuzumab+CAPEOX
    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;
  • Experimental: Cohort 2: HCB101+Ramucirumab+Paclitaxel
    HCB101: QW 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;
  • Experimental: Cohort 3a: HCB101 + Bevacizumab + FOLFIRI/ mFOLFOX6
    HCB101: QW Bevacizumab 5 mg/kg IV on D1, Q2W FOLFIRI: Irinotecan 180 mg/m2 IV on D1, Q2W Leucovorin 400 mg/m2 IV on D1, Q2W 5-FU 400 mg/m2 IV on D1, then 1200 mg/m2/day on D2 and D3 (total 2400 mg/m2), Q2W mFOLFOX6: Oxaliplatin 85 mg/m2 IV on D1, Q2W Leucovorin 400 mg/m2 IV on D1, Q2W 5-FU 400 mg/m2 IV on D1, then 1200 mg/m2/day on D2 and D3 (total 2400 mg/m2), Q2W
  • Experimental: Cohort 3b: HCB101 + Cetuximab + FOLFIRI/ mFOLFOX6
    HCB101: QW Cetuximab 400 mg/m2 IV on D1, then 250 mg/m2, weekly FOLFIRI: Irinotecan 180 mg/m2 IV on D1, Q2W Leucovorin 400 mg/m2 IV on D1, Q2W 5-FU 400 mg/m2 IV on D1, then 1200 mg/m2/day on D2 and D3 (total 2400 mg/m2), Q2W mFOLFOX6: Oxaliplatin 85 mg/m2 IV on D1, Q2W Leucovorin 400 mg/m2 IV on D1, Q2W 5-FU 400 mg/m2 IV on D1, then 1200 mg/m2/day on D2 and D3 (total 2400 mg/m2), Q2W
  • Experimental: Cohort 3c: HCB101 + Ramucirumab + FOLFIRI
    HCB101: QW Ramucirumab 8 mg/kg IV on D1 and 15, Q4W FOLFIRI: Irinotecan 180 mg/m2 IV on D1, Q2W Leucovorin 400 mg/m2 IV on D1, Q2W 5-FU 400 mg/m2 IV on D1, then 1200 mg/m2/day on D2 and D3 (total 2400 mg/m2), Q2W
  • Experimental: Cohort 3d: HCB101 + mFOLFOX6
    HCB101: QW mFOLFOX6: Oxaliplatin 85 mg/m2 IV on D1, Q2W Leucovorin 400 mg/m2 IV on D1, Q2W 5-FU 400 mg/m2 IV on D1, then 1200 mg/m2/day on D2 and D3 (total 2400 mg/m2), Q2W
  • Experimental: Cohort 4: HCB101 + Pembrolizumab/Toripalimab + albumin-bound paclitaxel
    HCB101, QW Pembrolizumab 200 mg IV on D1, Q3W or Toripalimab 240 mg IV on D1, Q3W Albumin-bound paclitaxel 100 mg/m2 on D1, 8, 15, Q4W or 125 mg/m2 IV on D1, D8, Q3W
  • Experimental: Cohort 5: HCB101 + Pembrolizumab + CAPEOX
    HCB101, QW Pembrolizumab 200 mg IV on D1, Q3W Oxaliplatin 130 mg/m2 IV on D1, Q3W Capecitabine 1000 mg/m2 PO BID on D1-14, Q3W
  • Experimental: Cohort 6a: HCB101 + Pembrolizumab
    HCB101, QW Pembrolizumab 200 mg IV on D1, Q3W
  • Experimental: Cohort 6b: HCB101 + Pembrolizumab + Cetuximab
    HCB101, QW Pembrolizumab 200 mg IV on D1, Q3W Cetuximab 400 mg/m2 IV on D1, then 250 mg/m2, QW
  • Experimental: Cohort 6c: HCB101 + Cetuximab
    HCB101, QW Cetuximab 400 mg/m2 IV on D1, then 250 mg/m2, QW
  • Experimental: Cohort 7: HCB101 + Trastuzumab Deruxtecan
    HCB101, QW Trastuzumab Deruxtecan 5.4 mg/kg IV on D1, Q3W
  • Experimental: Cohort 8: HCB101 + Atezolizumab/Toripalimab + Bevacizumab
    HCB101, QW Atezolizumab 1200 mg IV on D1, Q3W or Toripalimab 240 mg IV on D1, Q3W Bevacizumab 15 mg/kg IV on D1, Q3W
  • Experimental: Cohort 9: HCB101 + Atezolizumab/Toripalimab + carboplatin + etoposide.
    HCB101, QW Atezolizumab 1200 mg IV on D1, Q3W or Toripalimab 240 mg IV on D1, Q3W Carboplatin AUC=5, IV on D1, Q3W for 4 cycles Etoposide 100mg/m2, IV on D1, 2, 3, Q3W for 4 cycles

Primary Outcome Measure

Number/incidence and percentage of subjects with adverse events. [ Time Frame: 12 months ]

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