Study of AK119 in Subjects With Advanced Solid Tumors

NCT05173792 | Completed Phase 1

• 1 other identifier: AK119-103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

This is Phase 1, Multicenter, Open-Label, Dose-Escalation and Dose-Exploration Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of AK119 (Anti-CD73) in Subjects with Advanced or Metastatic Solid Tumors.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events (AEs)

  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  From the time of informed consent signed through 90 days after the last dose of study drug

• Number of participants with a Dose Limiting Toxicity (DLT)

  DLTs will be assessed during the first 4 weeks of treatment for dose-escalation phase and first 3 weeks for dose-exploration phase. DLTs 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 DLT observation period.

  During the first 4 weeks in dose-escalation phase, during the first 3 weeks in dose-exploration phase

Secondary Outcomes (5)

• Serum PK concentration of AK119

  From first dose of study drug through 30 days after last dose of study drug

• Number of subjects who develop detectable anti-drug antibodies (ADAs)

  From first dose of study drug through 90 days after last dose of study drug

• Objective response rate (ORR)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

Study Arms (1)

AK119

EXPERIMENTAL

Subjects will receive escalating doses of AK119 every 2 or 3 weeks.

Drug: AK119

Interventions

AK119 DRUG

Subjects will receive AK119 intravenously.

AK119

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to1.
• Life expectancy ≥12 weeks;
• Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and within 120 days after the last dose of investigational product.
• Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and within 120 days after the last dose of investigational product.
• Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor that is refractory or relapsed to the current standard therapies, or for which no effective standard therapy is available, or whereby standard therapy has been refused.
• Subjects must have evaluable lesions according to RECIST v1.1.
• Adequate organ function.

You may not qualify if:

• Prior malignancy active within the previous 3 years except for the tumor for which a subject is enrolled in the study, and locally curable cancers that have been apparently cured.
• Receipt of the following treatments or procedures:
• Anticancer small-molecule targeted agent (e.g., tyrosine kinase inhibitor) within 2 weeks prior to the first dose of investigational product;
• Anti-PD-1/PD-L1 mAb within 4 weeks prior to the first dose of investigational product;
• Prior use of approved or investigational anti-CTLA-4 therapy, anti-CD73 therapy or adenosine 2A receptor inhibitors, or any other antibody or drug targeting T cell costimulation or immune checkpoint pathways such as ICOS, or agonists such as CD40, CD137, GITR, OX40 etc.;
• Other anticancer mAb within 4 weeks or 5 half-lives (whichever is less) prior to the first dose of investigational product;
• Other anticancer therapy (e.g., chemotherapy, radiotherapy, etc.) within 4 weeks prior to the first dose of investigational product;
• Any major surgery within 4 weeks prior to the first dose of investigational product;
• Any other non-approved investigational product or procedure within 4 weeks prior to the first dose of investigational product, or concurrent participation in another therapeutic clinical study;
• Any topical therapy (e.g., TACE, HAIC, TARE) within 4 weeks prior to the first dose of investigational product;
• Subjects with history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at Screening;
• Brain stem metastasis, meningeal metastasis, spinal cord metasasis or compression;
• Uncontrolled massive ascites, pleural effusion or pericardial effusion, as determined by the Investigator;
• Known history of human immunodeficiency virus (HIV) infection;
• Known active hepatitis B or C infections (Active hepatitis B is defined as a known positive Hepatitis B surface antigen \[HBsAg\] result. Active hepatitis C is defined by a known positive Hepatitis C virus \[HCV\] antibody with detectable HCV ribonucleic acid \[RNA\] results);

Sponsors & Collaborators

• Akeso: lead

Study Sites (2)

Fudan University Zhongshan Hospital

Shanghai, 200032, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, 300060, China

Location

Study Officials

• Jihui Hao, PhD

  Tianjin Medical University Cancer Insitute & Hospital

  PRINCIPAL INVESTIGATOR

• Tianshu Liu

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 30, 2021
• Study Start: December 22, 2021
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

CN (2)