A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK137 (Bispecific Antibody Targeting CD73 and LAG-3) in Patients With Advanced Malignant Tumors

Akeso1 site in 1 country87 target enrollmentDecember 2024

ConditionsAdvanced Malignant Tumors

InterventionsAK137

DrugsAK137

Overview

Phase: Phase 1
Intervention: AK137
Conditions: Advanced Malignant Tumors
Sponsor: Akeso
Enrollment: 87
Locations: 1
Primary Endpoint: AEs
Status: Not yet recruiting
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 antitumor activity of AK137 in patients with advanced malignant tumors.

Registry

clinicaltrials.gov

Start Date

December 2024

End Date

August 2027

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.
•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-CD73, anti-LAG-3 treatment.
•Experienced a toxicity that led to the permanent discontinuation of prior immunotherapy. All adverse events (AEs) while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening. Additionally, the use of immunosuppression other than corticosteroids was required.
•Unresolved toxicities from prior anticancer therapy, defined as not having resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels specified in the inclusion/exclusion criteria, except for 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 AK137 or still recovering from prior surgery.
•History of organ transplant.
•Known allergy or reaction to any component of the AK137 formulation. History of severe hypersensitivity reactions to other mAbs.

Arms & Interventions

AK137

Each subject will receive a single dose of AK137 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: AK137

Outcomes

Primary Outcomes

AEs

Time Frame: From time ICF is signed until 90 days after last dose of AK137

Incidence and severity of participants with adverse events

DLT

Time Frame: During the first 28-day of treatment with AK137

Secondary Outcomes

Objective Response Rate (ORR)(Up to approximately 2 years)
Disease Control Rate (DCR)(Up to approximately 2 years)
Duration of Response (DoR)(Up to approximately 2 years)
Time to response (TTR)(Up to approximately 2 years)
Progression Free Survival (PFS)(Up to approximately 2 years)
Overall Survival (OS)(Up to approximately 2 years)
Cmax of AK137(From first dose of study drug through end of treatment (up to approximately 2 years))
Cmin of AK137(From first dose of study drug through end of treatment (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)