Clinical trial · Interventional
A Study of Anti-VEGFR2 AK109 in Subjects With Advanced Solid Tumors
A Phase I, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AK109，an Anti-VEGFR2 Monoclonal Antibody in Subjects With Advanced Solid Tumors
NCT04547205CI-TRIAL-00064184completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a first in human(FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity and anti-tumor activity of AK109, an anti-VEGFR2 monoclonal antibody, as a single agent in adult subjects with advanced solid tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK109 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AK109
- interventionNames
- Drug: AK109
Primary outcomes (1)
- measure
- Number of subjects experiencing dose-limiting toxicities (DLTs)
- timeFrame
- During the first 4 weeks
- description
- DLTs will be assessed during the first 4 weeks of treatment for dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (4 weeks) of treatment.
Secondary outcomes (7)
- measure
- Adverse events (AEs)
- timeFrame
- From the time of informed consent signed through to 60 days after last dose of AK109
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have signed written informed consent form voluntarily. * Histologically or cytologically documented advanced solid tumor that is refractory/relapsed/intolerant to standard therapies, or for which no effective standard therapy is available, or subject refuses standard therapy. * Have radiologically measurable disease based on RECIST 1.1 * ECOG of 0 or 1. * Estimated life expectancy of ≥3 months. * Adequate organ function. * Have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration. Exclusion Criteria: * have been diagnosed other advanced tumors within 2 years before the first use of the study drug, except for the cured localized tumors. * with active central nervous system metastasis, cancerous meningitis, or spinal cord compression. * Prior use of any anti-VEGF or anti-VEGFR antibodies. * Receipt of anti-tumor treatment, other study drug, major surgery, or serious infection within 4 weeks prior to C1D1 (Cycle 1 Day1, the first dose of study drug). * Have received central venous catheterization within 7 days prior to C1D1. * Severe or uncontrolled cardiovascular and cerebrovascular diseases. * Uncontrolled hypertension. * have a high risk of bleeding. * Uncontrolled gastrointestinal diseases. * Uncontrolled pleural/pericardial or peritoneal effusion. * Have occurred any thromboembolic event, non-gastrointestinal fistula or female genital tract fistula within 6 monthsprior to C1D1. * With cirrhosis of Child-Pugh B or C. * Active or unstable viral hepatitis; or active tuberculosis. * Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * received live vaccines prior 30 days within the first dose. * take apart in other clinical studies at the same time. * known to be allergic to any component of AK109, other monoclonal antibodies or any therapeutic protein. * mental illness, drug abuse, or alcohol dependence that may affect compliance with the test requirements. * Any treatment risk or condition that interferes with the study by the investigator judged.
References
Publications (1)
- DERIVEDZheng Y, Zhong H, Zhao F, Zhou H, Mao C, Lv W, Yuan M, Qian J, Jiang H, Wang Z, Xiao C, Guo J, Liu T, Liu W, Wang ZM, Li B, Xia M, Xu N. First-in-human, phase I study of AK109, an anti-VEGFR2 antibody in patients with advanced or metastatic solid tumors. ESMO Open. 2023 Apr;8(2):101156. doi: 10.1016/j.esmoop.2023.101156. Epub 2023 Mar 28. PMID 36989884