A Multicenter, Open-label, Phase Ib/II Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid Tumors

Akeso1 site in 1 country65 target enrollmentSeptember 10, 2019

ConditionsSolid Tumor Lung Cancer HCC

InterventionsAK105

DrugsAK105

Overview

Phase: Phase 1
Intervention: AK105
Conditions: Solid Tumor
Sponsor: Akeso
Enrollment: 65
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-center, multi-cohort, open-label, phase Ib/II study to evaluate the efficacy, safety, PK characteristics, immunogenicity and potential biomarkers of AK105 monotherapy in the patients with selected advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

September 10, 2019

End Date

January 30, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Akeso

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written and signed informed consent.
•Aged over 18 and less than 75 years at the time of signing the informed consent form, both female and male.
•ECOG PS is 0-
•The expected survival time is ≥ 3months
•Histologically or cytologically confirmed selected advanced solid tumor.
•Subject must have at least one measurable lesion according to RECIST Version1.
•Available archived tumor tissue sample to allow for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, the subject must consent and undergo fresh tumor biopsy.
•Adequate organ function.
•Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product.
•Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product.

Exclusion Criteria

•Had received experimental drug or used experimental device in the past within 4 weeks prior to the first dose of study drug.
•Receipt of last radiotherapy or any anti-tumor treatment \[chemotherapy, targeted therapy, immunotherapy, Chinese patent drugs with antitumor indications, or immunomodulators or tumor embolization\] within 4 weeks prior to the first dose of study drug.
•Had received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, etc.), or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways (such as ICOS, CD40, CD137, GITR, OX40 antibody or drug), immunocytotherapy, therapeutic antibody, etc.).
•Toxicity from previous anti-cancer therapy has not been alleviated or resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria.
•Patients with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave disease, psoriasis or eczema not requiring systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses of hormone replacement therapy and type I diabetes only requiring steady doses of insulin replacement therapy, or completely relieved childhood asthma that requires no intervention in adulthood, or primary diseases that will not relapse unless triggered by external factors.
•Active or previously recorded inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea).
•Patients with a condition requiring systemic treatment with either corticosteroid (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
•Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
•Large surgical procedures (defined by researchers as open biopsy, severe trauma, etc.) were performed within 28 days prior to the first dose of study drug.
•Known history of interstitial lung disease.

Arms & Interventions

AK105

AK105 200 mg, every 2 weeks

Intervention: AK105

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: Up to 2 years

The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

Secondary Outcomes

Disease control rate (DCR)(Up to 2 years)
Number of participants with adverse events (AEs)(the time of informed consent signed through 90 days after the last dose of AK105)
Progression-free survival (PFS)(Up to 2 years)
Duration of response (DoR)(Up to 2 years)
Minimum observed concentration (Cmin) of AK105 at steady state(From first dose of AK105 through to 90 days after last dose of AK105)
Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of AK105 through to 90 days after last dose of AK105)