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NCT04597541

A Study of AK112 for Advanced Solid Tumors

Completed Phase 1, PHASE2 Last updated 10 March 2025
What this trial tests

Phase 1, PHASE2 trial testing AK112 in Solid Tumor, Adult in 59 participants. Completed in 15 July 2024.

Timeline
21 October 2020
Primary endpoint
31 March 2022
15 July 2024

Quick facts

Lead sponsorAkeso
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment59
Start date21 October 2020
Primary completion31 March 2022
Estimated completion15 July 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Akeso — full company profile →

Who can join

Adults 18 to 75, any sex, with Solid Tumor, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK112, a PD-1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumor malignancies. This trial is a two parts, phase I/II study. All patients are advanced solid tumor, Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Part one is dose escalation phase,part two is dose expansion phase. The primary end point is safety. Secondary end points are objective response rate,progression-free survival and overall survival per RECIST1.1.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Dual blockade immunotherapy targeting PD-1/PD-L1 and CTLA-4 in lung cancer.
    Cheng W, Kang K, Zhao A, Wu Y. · · 2024 · cited 110× · PMID 39068460 · DOI 10.1186/s13045-024-01581-2
  2. Bispecific Antibodies in Cancer Immunotherapy: A Novel Response to an Old Question.
    Ordóñez-Reyes C, Garcia-Robledo JE, Chamorro DF, Mosquera A, et al · · 2022 · cited 22× · PMID 35745815 · DOI 10.3390/pharmaceutics14061243
  3. Clinical Progresses and Challenges of Bispecific Antibodies for the Treatment of Solid Tumors.
    Gu Y, Zhao Q. · · 2024 · cited 16× · PMID 39172329 · DOI 10.1007/s40291-024-00734-w
  4. Insights into next-generation immunotherapy designs and tools: molecular mechanisms and therapeutic prospects.
    Qin H, Zhou Z, Shi R, Mai Y, et al · · 2025 · cited 15× · PMID 40483473 · DOI 10.1186/s13045-025-01701-6
  5. Revolutionizing cancer immunotherapy: unleashing the potential of bispecific antibodies for targeted treatment.
    Guo X, Wu Y, Xue Y, Xie N, et al · · 2023 · cited 15× · PMID 38106416 · DOI 10.3389/fimmu.2023.1291836
  6. Leading Edge: Intratumor Delivery of Monoclonal Antibodies for the Treatment of Solid Tumors.
    Blanco E, Chocarro L, Fernández-Rubio L, Bocanegra A, et al · · 2023 · cited 12× · PMID 36768997 · DOI 10.3390/ijms24032676
  7. Safety, Pharmacokinetics, and Pharmacodynamics Evaluation of Ivonescimab, a Novel Bispecific Antibody Targeting PD-1 and VEGF, in Chinese Patients With Advanced Solid Tumors.
    Wang F, Wei X, Zheng Y, Wang J, et al · · 2025 · cited 7× · PMID 40114411 · DOI 10.1002/cam4.70653
  8. Current Indications and Future Landscape of Bispecific Antibodies for the Treatment of Lung Cancer.
    Arasanz H, Chocarro L, Fernández-Rubio L, Blanco E, et al · · 2023 · cited 6× · PMID 37373003 · DOI 10.3390/ijms24129855

Verify or expand the search:

Other trials of AK112

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Other Akeso trials

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04597541.

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