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A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104

A Phase 1 Multicenter, Open Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104 in Subjects With Relapsed/Refractory Advanced or Metastatic Solid Tumors or Lymphomas

NCT04349969•Akesobio Australia Pty Ltd

View on ClinicalTrials.gov

Summary

This was a first-in-human, Phase 1 study designed to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK117 as monotherapy or in combination with AK104 in subjects with advanced or metastatic solid tumors.

Detailed Description

The study was conducted across 2 parts. Part A of the study was the dose escalation part of AK117 monotherapy as priming dose to evaluate the safety and tolerability of AK117 weekly dosing in solid tumors. Part B which was to evaluate the optimal maintenance dose of AK117 was not performed as the MAD dose level of AK117 monotherapy was determined in Part A. Part A2 was the dose escalation part of AK117 in combination with AK104 to evaluate the safety and tolerability of AK117 monotherapy in solid tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Able to provide written and signed informed consent
•2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
•3. Life expectancy ≥12 weeks
•4. Females of childbearing potential and non-sterilized males who are sexually active must use an effective method of contraception from screening until 120 days after final dose of investigational product or women of non-childbearing potential.
•5. Willing to receive blood transfusion(s) when so advised by the investigator.
•6. Adequate organ function.
•7. Subjects must have a histologically or cytologically confirmed advanced solid tumor that is refractory or relapsed to the current standard therapies or which no effective standard therapy is available.
•8. At least 1 measurable lesion according to RECIST v1.1

Exclusion Criteria

•1. Concurrent enrollment in another clinical study excluding observational trials
•2. Prior malignancy active within the previous 3 years except for the tumor for which a subject is enrolled in the study
•3. Active brain/central nervous system (CNS) metastases
•4. Active infections requiring systemic therapy within 2 weeks prior to the first dose of investigational product.
•5. Known history of HIV.
•6. Known active hepatitis B or C infections
•7. Active or prior documented autoimmune disease that may relapse.
•8. History of interstitial lung disease or non-infectious pneumonitis, except those induced by radiation therapies.
•9. History of defects in RBC production, or hemoglobin production or metabolism
•10. Patients with clinically significant cardio-cerebrovascular disease.
+5 more criteria

Locations (4)

Blacktown Hospital

Sydney, New South Wales, Australia

ICON Cancer Foundation

South Brisbane, Queensland, Australia

Ashford Cancer Centre Research

Kurralta Park, South Australia, Australia

Austin Health

Heidelberg, Victoria, Australia

Key Dates

Start Date

April 23, 2020

Primary Completion Date

November 8, 2022

Completion Date

November 8, 2022

Last Updated

August 21, 2024

Enrollment

ACTUAL participants

Conditions

Neoplasms Malignant

Interventions

AK117

DRUG

AK117+AK104

DRUG

Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.

NCT06778382

Colorectal Neoplasms Malignant

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RECRUITINGPHASE3

Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

NCT05939687

Neoplasms MalignantRectal Cancer+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104

Inclusion Criteria

Exclusion Criteria

Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.

Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

Local Cecal Cancer - Optimization of Surgical Treatment

Predicting Local and Distant Recurrence in T1 Colorectal Cancer

A Phase 1 Dose Escalation and Expansion Study of AK117

A Study of AK112, a PD-1/VEGF Bispecific Antibody, for Advanced Solid Tumors