A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114

A Phase 1a, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114 in Subjects With Advanced or Metastatic Solid Tumors

A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK114.

Study Overview

• Status: Not yet recruiting
• Conditions: Metastasis; Advanced or Metastatic Solid Tumors; Malignancy
• Intervention / Treatment: Drug: AK114

Detailed Description

This is a first-in-human (FIH), Phase 1a, multicenter, open-label, single-arm dose-escalation study of AK114 to evaluate the safety, tolerability, PK, pharmacodynamics, antitumor activity and immunogenicity in adult subjects with advanced or metastatic solid tumors. The study is comprised of dose escalation phase. Approximately 30 subjects will be treated in this study.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Alex HL Wong, MMedSc; Phone Number: +86(0760)89873999; Email: global.trials@akesobio.com

Study Locations

• Australia
  • South Australia
    • Kurralta Park, South Australia, Australia
      • Ashford Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Written and signed informed consent
2. Age ≥ 18
3. Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor
4. Subject must have at least one measurable lesion according to RECIST v1.1
5. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1
6. At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated
7. Available archived tumor tissue sample (block or a minimum of 10 unstained slides of formalin-fixed paraffin-embedded tissues) to allow for correlative biomarker studies
8. Subjects may opt to provide two fresh biopsy samples (pretreatment and on treatment), where clinically appropriate
9. Adequate organ function
10. Use acceptable method of contraception from screening, and must agree to continue for 120 days after the final dose of investigational product

Exclusion Criteria:

1. History of severe hypersensitivity reactions to other monoclonal antibodies
2. History or concurrent gastrointestinal perforation, surgery and wound healing complications, hemorrhage events
3. Patients with clinically significant cardiovascular disease
4. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of investigational product administration
5. Active or prior documented autoimmune disease within the past 2 years
6. History of primary immunodeficiency
7. History of organ transplant or hematopoietic stem cell that requires use of immunosuppressive medications
8. Known allergy or reaction to any component of the investigational product formulation.
9. History of interstitial lung disease or noninfectious pneumonitis except for those induced by radiation therapies.
10. Prior treatment with canakinumab.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention/treatment; Experimental	Drug: AK114; AK114 administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of 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 drug, whether or not considered related to the study drug.	From the time of informed consent signed through to 90 days after last dose of study drug
Number of participants with a Dose Limiting Toxicity (DLTs)	DLTs will be assessed as having a suspected relationship to study drug according to pre-specific criteria in the protocol.	Within the first 28 days after receiving the first dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum pharmacokinetics (PK)	Serum concentrations of study drug in individual subjects at different time points after study drug administration	From first dose of treatment through to 90 days after end of treatment
Number of subjects who develop detectable anti-drug antibodies (ADAs)	The immunogenicity of study drug will be assessed by summarizing the number of subjects who develop detectable ADAs.	From first dose of study drgu through to 90 days after end of treatment
Objective response rate (ORR)	The ORR is defined as the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR), based on RECIST Version 1.1.	Up to 2 years
Disease control rate (DCR)	DCR is defined as the number (%) of subjects with best of response of confirmed CR or PR, or stable disease (SD) according to RECIST v1.1.	Up to 2 years

Collaborators and Investigators

• Sponsor: Akeso
• Investigators: Study Director: Alex HL Wong, MMedSc, Akeso

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: AK114-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No