A Study of Anti-VEGFR2 AK109 in Subjects With Advanced Solid Tumors

NCT04547205 | Completed Phase 1

• 1 other identifier: AK109-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Number of subjects experiencing dose-limiting toxicities (DLTs)

  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.

  During the first 4 weeks

Secondary Outcomes (7)

• Adverse events (AEs)

  From the time of informed consent signed through to 60 days after last dose of AK109

• Objective response rate (ORR)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (1)

AK109

EXPERIMENTAL

Drug: AK109

Interventions

AK109 DRUG

AK109, 2#4#8#12#18mg/kg, IV, every 2 weeks (Q2W), or 15 mg/kg every 3 weeks(Q3W)

AK109

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

The First Affiliated Hospital of Medicine College, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

• Zheng 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 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 14, 2020
• Study Start: June 6, 2020
• Primary Completion: March 24, 2021
• Study Completion: October 31, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)