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

Primary Purpose

Advanced or Metastatic Solid Tumors, Malignancy, Metastasis

Status

Not yet recruiting

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

AK114

About this trial

This is an interventional treatment trial for Advanced or Metastatic Solid Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written and signed informed consent
Age ≥ 18
Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor
Subject must have at least one measurable lesion according to RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1
At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated
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
Subjects may opt to provide two fresh biopsy samples (pretreatment and on treatment), where clinically appropriate
Adequate organ function
Use acceptable method of contraception from screening, and must agree to continue for 120 days after the final dose of investigational product

Exclusion Criteria:

History of severe hypersensitivity reactions to other monoclonal antibodies
History or concurrent gastrointestinal perforation, surgery and wound healing complications, hemorrhage events
Patients with clinically significant cardiovascular disease
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
Active or prior documented autoimmune disease within the past 2 years
History of primary immunodeficiency
History of organ transplant or hematopoietic stem cell that requires use of immunosuppressive medications
Known allergy or reaction to any component of the investigational product formulation.
History of interstitial lung disease or noninfectious pneumonitis except for those induced by radiation therapies.
Prior treatment with canakinumab.

Sites / Locations

Ashford Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention/treatment

Arm Description

Experimental

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Serum pharmacokinetics (PK)

Serum concentrations of study drug in individual subjects at different time points after study drug administration

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.

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.

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.

Full Information

NCT ID

NCT05200273

First Posted

January 7, 2022

Last Updated

January 7, 2022

Sponsor

Akeso

1. Study Identification

Unique Protocol Identification Number

NCT05200273

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 15, 2022 (Anticipated)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Akeso

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced or Metastatic Solid Tumors, Malignancy, Metastasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Non Randomised

Masking

None (Open Label)

Masking Description

None (open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention/treatment

Arm Type

Experimental

Arm Description

Experimental

Intervention Type

Drug

Intervention Name(s)

AK114

Intervention Description

AK114 administered by subcutaneous injection

Primary Outcome Measure Information:

Title

Incidence of adverse events (AEs)

Description

Time Frame

From the time of informed consent signed through to 90 days after last dose of study drug

Title

Number of participants with a Dose Limiting Toxicity (DLTs)

Description

DLTs will be assessed as having a suspected relationship to study drug according to pre-specific criteria in the protocol.

Time Frame

Within the first 28 days after receiving the first dose of study drug

Secondary Outcome Measure Information:

Title

Serum pharmacokinetics (PK)

Description

Serum concentrations of study drug in individual subjects at different time points after study drug administration

Time Frame

From first dose of treatment through to 90 days after end of treatment

Title

Number of subjects who develop detectable anti-drug antibodies (ADAs)

Description

The immunogenicity of study drug will be assessed by summarizing the number of subjects who develop detectable ADAs.

Time Frame

From first dose of study drgu through to 90 days after end of treatment

Title

Objective response rate (ORR)

Description

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.

Time Frame

Up to 2 years

Title

Disease control rate (DCR)

Description

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.

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written and signed informed consent Age ≥ 18 Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor Subject must have at least one measurable lesion according to RECIST v1.1 Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1 At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated 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 Subjects may opt to provide two fresh biopsy samples (pretreatment and on treatment), where clinically appropriate Adequate organ function Use acceptable method of contraception from screening, and must agree to continue for 120 days after the final dose of investigational product Exclusion Criteria: History of severe hypersensitivity reactions to other monoclonal antibodies History or concurrent gastrointestinal perforation, surgery and wound healing complications, hemorrhage events Patients with clinically significant cardiovascular disease 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 Active or prior documented autoimmune disease within the past 2 years History of primary immunodeficiency History of organ transplant or hematopoietic stem cell that requires use of immunosuppressive medications Known allergy or reaction to any component of the investigational product formulation. History of interstitial lung disease or noninfectious pneumonitis except for those induced by radiation therapies. Prior treatment with canakinumab.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alex HL Wong, MMedSc

Phone

+86(0760)89873999

global.trials@akesobio.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alex HL Wong, MMedSc

Organizational Affiliation

Akeso

Official's Role

Study Director

Facility Information:

Facility Name

Ashford Cancer Centre

City

Kurralta Park

State/Province

South Australia

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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