A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AK130 (TIGIT/TGF-β Bifunctional Fusion Protein) in Patients With Advanced Malignant Tumors

Akeso1 site in 1 country19 target enrollmentFebruary 9, 2023

ConditionsAdvanced Malignant Tumors

InterventionsAK130

DrugsAK130

Overview

Phase: Phase 1
Intervention: AK130
Conditions: Advanced Malignant Tumors
Sponsor: Akeso
Enrollment: 19
Locations: 1
Primary Endpoint: Number of participants with DLTs
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AK130 (TIGIT/TGF-β bifunctional fusion protein) in patients with advanced malignant tumors.

Registry

clinicaltrials.gov

Start Date

February 9, 2023

End Date

May 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Akeso

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written and signed informed consent and any locally required authorization obtained from the subject/legal representative.
•Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or
•Life expectancy ≥3 months.
•Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
•Subject must have at least one measurable lesion according to RECIST Version1.
•Adequate organ function.

Exclusion Criteria

•Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast.
•Receipt of any anti-TIGIT, anti-TGF-β treatment.
•Experienced a toxicity that led to permanent discontinuation of prior immunotherapy. All AEs while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening, required the use of additional immunosuppression other than corticosteroids.
•Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1，or to levels dictated in the inclusion/exclusion criteria, except toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities).
•Major surgical procedure within 4 weeks prior to the first dose of AK130 or still recovering from prior surgery.
•History of organ transplant.
•Known allergy or reaction to any component of the AK130 formulation. History of severe hypersensitivity reactions to other mAbs.

Arms & Interventions

AK130

Each subject will receive a single dose of AK130 every 3-week cycle (Q3W) or every 2-week cycle (Q2W). Participants may continue on study drug until unacceptable toxicity, or other withdrawal criteria is met.

Intervention: AK130

Outcomes

Primary Outcomes

Number of participants with DLTs

Time Frame: During the first four weeks of treatment with AK130

Incidence and severity of participants with adverse events (AEs)

Time Frame: From time ICF is signed until 90 days after last dose of AK130

Secondary Outcomes

Duration of Response (DOR)(Up to approximately 2 years)
Objective response rate (ORR)(Up to approximately 2 years)
Progression-free survival (PFS)(Up to approximately 2 years)
Time to response (TTR)(Up to approximately 2 years)
Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of study drug through 30 days after last dose of study drug)
Disease control rate (DCR)(Up to approximately 2 years)
Maximum observed concentration (Cmax) of AK130(From first dose of study drug through end of treatment (up to approximately 2 years))
Minimum observed concentration(Cmin) of AK130(From first dose of study drug through end of treatment (up to approximately 2 years))
Overall survival (OS)(Up to approximately 2 years)
Area under the curve (AUC) of AK130 for assessment of pharmacokinetics(From first dose of study drug through end of treatment (up to approximately 2 years))