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

NCT05200273 | Unknown Phase 1

• 1 other identifier: AK114-102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced or Metastatic Solid Tumors; Malignancy; Metastasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Serum pharmacokinetics (PK)

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

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

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

• Objective response rate (ORR)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

Study Arms (1)

Intervention/treatment

EXPERIMENTAL

Experimental

Drug: AK114

Interventions

AK114 DRUG

AK114 administered by subcutaneous injection

Intervention/treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Ashford Cancer Centre

Kurralta Park, South Australia, Australia

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alex HL Wong, MMedSc

  Akeso

  STUDY DIRECTOR

Central Study Contacts

Alex HL Wong, MMedSc

CONTACT

+86(0760)89873999; global.trials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: None (open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non Randomised

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 20, 2022
• Study Start: March 15, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)