NCT04047290

A Study of AK112, a PD-1/VEGF Bispecific Antibody, for Advanced Solid Tumors

Completed Phase 1 Last updated 28 February 2025

What this trial tests

Phase 1 trial testing AK112 in Neoplasms Malignant in 80 participants. Completed in 27 February 2024.

Timeline

20 September 2019

Primary endpoint
27 February 2024

27 February 2024

Quick facts

Lead sponsor	Akesobio Australia Pty Ltd
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	20 September 2019
Primary completion	27 February 2024
Estimated completion	27 February 2024
Sites	7 locations across Australia

Drugs / interventions tested

• AK112 — full drug profile →

Conditions studied

• Neoplasms Malignant — all drugs for Neoplasms Malignant →

Sponsor

Akesobio Australia Pty Ltd — full company profile →

Who can join

18 and older, any sex, with Neoplasms Malignant. 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. The study consists of a dose escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK112 as a single agent, and a dose expansion phase (Phase 1b) in subjects with specific tumor types which will characterize treatment of AK112 as a single agent at the MTD or RP2D.

Publications & conference data

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

1. Emerging new therapeutic antibody derivatives for cancer treatment.
   Jin S, Sun Y, Liang X, Gu X, et al · · 2022 · cited 304× · PMID 35132063 · DOI 10.1038/s41392-021-00868-x
2. Current landscape and future directions of bispecific antibodies in cancer immunotherapy.
   Wei J, Yang Y, Wang G, Liu M. · · 2022 · cited 127× · PMID 36389699 · DOI 10.3389/fimmu.2022.1035276
3. 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
4. Biology drives the discovery of bispecific antibodies as innovative therapeutics.
   Nie S, Wang Z, Moscoso-Castro M, D'Souza P, et al · · 2020 · cited 79× · PMID 33928225 · DOI 10.1093/abt/tbaa003
5. Bispecific antibodies targeting immunomodulatory checkpoints for cancer therapy.
   Zhang T, Lin Y, Gao Q. · · 2023 · cited 47× · PMID 36971124 · DOI 10.20892/j.issn.2095-3941.2023.0002
6. Phase 1a dose escalation study of ivonescimab (AK112/SMT112), an anti-PD-1/VEGF-A bispecific antibody, in patients with advanced solid tumors.
   Frentzas S, Austria Mislang AR, Lemech C, Nagrial A, et al · · 2024 · cited 46× · PMID 38642937 · DOI 10.1136/jitc-2023-008037
7. Advances in targeting tumor microenvironment for immunotherapy.
   Wang L, Zhang L, Zhang Z, Wu P, et al · · 2024 · cited 34× · PMID 39421736 · DOI 10.3389/fimmu.2024.1472772
8. Disrupting cancer angiogenesis and immune checkpoint networks for improved tumor immunity.
   Anderson TS, Wooster AL, Piersall SL, Okpalanwaka IF, et al · · 2022 · cited 23× · PMID 35149179 · DOI 10.1016/j.semcancer.2022.02.009