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

Metastasis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05200273
• Other study ID #: AK114-102
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 15, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2022
• Source: Akeso
• Contact: Alex HL Wong, MMedSc
• Phone: +86(0760)89873999
• Email: global.trials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumors
• Malignancy
• Metastasis
• Neoplasms

Intervention

Drug:
• AK114
AK114 administered by subcutaneous injection

Locations

Country	Name	City	State
Australia	Ashford Cancer Centre	Kurralta Park	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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