A Study of AK130 in Patients With Advanced Malignant Tumors

NCT05653284 | Completed Phase 1

• 1 other identifier: AK130-101
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of participants with adverse events (AEs)

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

• Number of participants with DLTs

  During the first four weeks of treatment with AK130

Secondary Outcomes (10)

• Objective response rate (ORR)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

• Progression-free survival (PFS)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

• Duration of Response (DOR)

  Up to approximately 2 years

Study Arms (1)

AK130

EXPERIMENTAL

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.

Drug: AK130

Interventions

AK130 DRUG

IV infusion, specified dose on specified days.

AK130

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.
• 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 Version1.1.
• Adequate organ function.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

The Cancer Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Location

Study Officials

• Jinming Yu

  The Cancer Hospital Affiliated to Shandong First Medical University

  PRINCIPAL INVESTIGATOR

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: November 25, 2022
• First Posted: December 16, 2022
• Study Start: February 9, 2023
• Primary Completion: December 12, 2023
• Study Completion: May 30, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

CN (1)