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A Study of AK112, a PD-1/VEGF Bispecific Antibody, for Advanced Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase 1a/1b, Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK112 in Subjects With Advanced Solid Tumors

NCT04047290•Akesobio Australia Pty Ltd

View on ClinicalTrials.gov

Summary

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK112, a PD-1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumor malignancies. The study consists of a dose escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK112 as a single agent, and a dose expansion phase (Phase 1b) in subjects with specific tumor types which will characterize treatment of AK112 as a single agent at the MTD or RP2D.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written and signed informed consent and any locally required authorization obtained from the subject/legal representative.
•In dose-escalation cohorts (Phase 1a), histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.
•In the dose-expansion cohorts (Phase 1b), histologically or cytologically confirmed selected advanced solid tumors.
•Subject must have at least one measurable lesion according to RECIST Version1.1.
•Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
•Available archived tumor tissue sample to allow for correlative biomarker studies. If unavailable or unsuitable, the subject must consent and undergo fresh tumor biopsy.
•Adequate organ function.
•Subjects with central nervous system (CNS) metastases must have been treated, be asymptomatic.
•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 child bearing potential.
•Life expectancy ≥12 weeks.
+2 more criteria

Exclusion Criteria

•History of severe hypersensitivity reactions to other mAbs.
•Prior malignancy active within the previous 3 years except for the tumor for which a subject is enrolled in the study, and locally curable cancers that have been apparently cured, (e.g. basal cell skin cancer, or carcinoma in situ of the cervix or breast).
•For subjects enrolled in the dose escalation phase, having received prior anti-PD-1, anti-PD-L1, anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 28 days of commencing treatment with AK112 or experienced a toxicity that led to permanent discontinuation of prior immunotherapy. All AEs while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening, required the use of additional immunosuppression other than corticosteroids
•Receiving any immunotherapy, conventional or investigational systemic anticancer therapy within 4 weeks prior to the first dose
•Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment (hormones use for non-cancer related conditions is acceptable).
•Subjects with clinically significant cardiovascular disease
•Subjects with a condition requiring systemic treatment with either corticosteroid (\> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration.
•Current or recent use of aspirin (\> 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.
•Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for \> 2 weeks prior to the first dose of AK112
•Active or prior documented autoimmune disease within the past 2 years or conditions not expected to recur in the absence of an external trigger)
+8 more criteria

Locations (7)

Border Medical Oncology

Albury, New South Wales, Australia

Scientia Clinical Research Ltd

Randwick, New South Wales, Australia

Blacktown Hospital

Sydney, New South Wales, Australia

ICON Cancer Foundation

South Brisbane, Queensland, Australia

Adelaide Cancer Centre

Kurralta Park, South Australia, Australia

Monash Health

Clayton, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Key Dates

Start Date

September 20, 2019

Primary Completion Date

February 27, 2024

Completion Date

February 27, 2024

Last Updated

February 28, 2025

Enrollment

ACTUAL participants

Conditions

Neoplasms Malignant

Interventions

AK112

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: February 28, 2025Data 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.

View ClinicalTrials.gov Terms and Conditions

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

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