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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Enrollment target: 150 to 500v4 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Interventions: 5-FU (Drug), Albumin-bound paclitaxel (Drug), Bevacizumab (Drug), Capecitabine (Drug), Cetuximab (Drug), Gemcitabine (Drug), HCB101 (Drug)… to 5-FU (Drug), Albumin-bound paclitaxel (Drug), Atezolizumab (Drug), Bevacizumab (Drug), Capecitabine (Drug), Carboplatin (AUC 5) (Drug)…
    • Eligibility criteria expanded, about 17 words
    • Site details revised
    • Study arms: 4 to 14
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 31, 2025 to Mar 13, 2025
    v3
  3. Primary endpoints revised (2)v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06771622
Lead Sponsor FBD Biologics Limited
Conditions
(from sponsor)		 Solid Cancer
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov