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A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab or SOC in HCC Patients

StatusEnrolling by Invitation
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 62 to 118 Primary completion date: Jul 20, 2024 to Dec 31, 2028 · Primary endpoints: 2 to 4 · Trial status: Recruiting to Enrolling by Invitation · 7 morev3 Show 10 more changesShow less
    • Primary completion date: Jul 20, 2024 to Dec 31, 2028
    • Primary endpoints: 2 to 4
    • Trial status: Recruiting to Enrolling by Invitation
    • Completion date: Oct 10, 2024 to Dec 31, 2029
    • Interventions: ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w (Drug) to ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w (Drug), ABSK-011 200mg BID combined with atilizumab 1200 mg q3w and bevacizumab…
    • Eligibility criteria expanded, about 158 words
    • Study description expanded, about 242 words
    • Site details revised
    • Study arms: 1 to 3
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Primary endpoints revised (2) · Study sites: 0 to 1 · Start date changed from estimate of Jul 28, 2022 to Dec 30, 2021 · 1 morev2 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 28, 2022 to Dec 30, 2021
    • Study title shortened, about 13 words

    See this version in full on ClinicalTrials.gov ↗

  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is an open phase II clinical study, which consists of part a and Part B. Part a will evaluate the safety and tolerability of absk-011 combined with atilizumab in patients with advanced or unresectable HCC to And pk/pd characteristics, and determine the treatment plan of Part B. Part B will evaluate absk-011 combined with atilizumab Anti FGF19 overexpression in advanced stage or non resectable patients who have not received systemic therapy or only received first-line systemic therapy before In addition to the safety and tolerability of HCC subjects, the antitumor activity of the combination will be further evaluated. Part C comprises two parts: Part C1 and Part C2. A maximum of 54 subjects with advanced or unresectable hepatocellular carcinoma (HCC) with FGF19 overexpression and no prior systemic therapy will be planned for enrollment. Eligible subjects will be prioritized for assignment to Part C2 to receive study treatment. Treatment will continue until the earliest occurrence of intolerable toxicity, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or study termination.
Trial Details
NCT Number NCT05441475
Lead Sponsor Abbisko Therapeutics Co, Ltd
Conditions Hepatocellular Carcinoma
Enrollment 118 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov