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Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 in Advanced Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Eligibility criteria expanded, about 27 words
    • Collaborator revised
  2. Re-verified, no change to tracked fieldsv9
  3. Site details revised at 5 of 5 sitesv8
  4. Study sites: 4 to 5
    • Eligibility criteria shortened, about 26 words
    v7
  5. Primary completion date: Dec 23, 2025 to Dec 30, 2026v6 Show 8 more changesShow less
    • Enrollment target: 160 to 218
    • Study sites: 3 to 4
    • Study completion date: Dec 7, 2026 to Dec 30, 2027
    • Interventions: ABO2011 Injection (Drug) to ABO2011 Injection (Drug), Toripalimab (Drug)
    • Eligibility criteria shortened, about 6 words
    • Study arms: 1 to 2
    • Collaborators expanded, about 5 words
    • Study title shortened, about 1 word
Show 4 earlier versionsHide 4 earlier versions
  1. Primary endpoints revised (5)v5
  2. Phase: Phase 1 to Phase 1/2v4 Show 8 more changesShow less
    • Enrollment target: 40 to 160
    • Primary completion date: May 23, 2025 to Dec 23, 2025
    • Primary endpoints revised (5)
    • Trial status: Enrolling by Invitation to Recruiting
    • Study completion date: Nov 7, 2025 to Dec 7, 2026
    • Eligibility criteria shortened, about 36 words
    • Site details revised at 3 of 3 sites
    • Study title expanded, about 2 words
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised at 3 of 3 sites
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 an open-label, single-arm, dose-escalation, and dose-expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ABO2011 monotherapy or in combination with Toripalimab in patients with advanced solid tumors.
Trial Details
NCT Number NCT06088004
Lead Sponsor Suzhou Abogen Biosciences Co., Ltd.
Collaborators: Abogen Life Sciences (Shanghai) Co., Ltd.
Conditions
(from sponsor)		 Solid Tumor, Adult
Enrollment 218 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov