A Study of AK130 in Patients With Advanced Malignant Tumors

NCT ID: NCT05653284

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-09
• Study Completion Date: 2024-05-30

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.

Conditions

Advanced Malignant Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AK130

Intervention Type: DRUG

IV infusion, specified dose on specified days.

Interventions

AK130

IV infusion, specified dose on specified days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written and signed informed consent and any locally required authorization obtained from the subject/legal representative.

2. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.

3. Life expectancy ≥3 months.

4. 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.

5. Subject must have at least one measurable lesion according to RECIST Version1.1.

6. Adequate organ function.

Exclusion Criteria

1. 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.

2. Receipt of any anti-TIGIT, anti-TGF-β treatment.

3. 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.

5. Major surgical procedure within 4 weeks prior to the first dose of AK130 or still recovering from prior surgery.

6. History of organ transplant.

7. Known allergy or reaction to any component of the AK130 formulation. History of severe hypersensitivity reactions to other mAbs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinming Yu

Role: PRINCIPAL_INVESTIGATOR

The Cancer Hospital Affiliated to Shandong First Medical University

Locations

The Cancer Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Countries

China

Other Identifiers

AK130-101

Identifier Type: -

Identifier Source: org_study_id