deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT04444167

A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma

An Open-Label Multi-Center Phase Ib/II Study of Anti-PD-1/CTLA-4 Bispecific Antibody AK104 in Combination With Lenvatinib As the First-Line Therapy for Patients With Advanced Hepatocellular Carcinoma

Sponsor: Akeso

Interventions AK104 Lenvatinib
Updated 8 times since 2020 Last updated: Apr 23, 2024 Started: Jul 7, 2020 Primary completion: Nov 20, 2023 Completion: Nov 20, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Hepatocellular Carcinoma and is currently completed. Akeso leads this study, which shows 8 recorded versions since 2020 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

This is a multi-center, multi-cohort, open-label phase 1b/2 clinical study to evaluate the anti-tumor activity, safety, PK profile, immunogenicity and potential biomarkers of AK104 plus lenvatinib for the treatment of advanced hepatocellular carcinoma.

This is a multi-center, multi-cohort, open-label phase 1b/2 clinical study to evaluate the anti-tumor activity, safety, PK profile, immunogenicity and potential biomarkers of AK104 plus lenvatinib for the treatment of advanced hepatocellular carcinoma.

Status Flow

~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshotRecruiting~Jan 2021 – ~Jul 2022 · 18 months · monthly snapshotRecruiting~Jul 2022 – ~Nov 2022 · 4 months · monthly snapshot~Nov 2022 – ~May 2024 · 18 months · monthly snapshotRecruiting~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshot

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  4. May 2024 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

    Status: RecruitingCompleted

  5. Nov 2022 — May 2024 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Unknown StatusRecruiting

Show 3 earlier versions
  1. Jul 2022 — Nov 2022 [monthly]

    Unknown Status PHASE1_PHASE2

    Status: RecruitingUnknown Status

  2. Jan 2021 — Jul 2022 [monthly]

    Recruiting PHASE1_PHASE2

  3. Jul 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Akeso
  • Akeso Pharmaceuticals, Inc.
Data source: Akeso

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations