A Single-arm, Open-label, Multicenter, Phase II Study of AK104 in Patients With Metastatic Nasopharyngeal Carcinoma Who Have Progressed After At Least 2 Prior Lines of Chemotherapy

Akeso1 site in 1 country34 target enrollmentApril 26, 2020

ConditionsNasopharyngeal Carcinoma

InterventionsAK104

DrugsAK104

Overview

Phase: Phase 2
Intervention: AK104
Conditions: Nasopharyngeal Carcinoma
Sponsor: Akeso
Enrollment: 34
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-arm, open-label, multicenter, phase II study to evaluate the anti-tumor activity, PK and immunogenicity of AK104 in patients with metastatic nasopharyngeal carcinoma who have progressed after at least 2 prior lines of systemic chemotherapy (of which one of them must be platinum-based chemotherapy).

Registry

clinicaltrials.gov

Start Date

April 26, 2020

End Date

August 23, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Akeso

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed written informed consent form voluntarily.
•Age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF.
•Eastern Cooperative Oncology Group (ECOG) performance score 0 or
•Expected life expectance ≥ 3 months.
•Histologically confirmed diagnosis of nonkeratinizing differentiated or undifferentiated NPC.
•Not suitable for radical local therapy.
•Stage IVb metastatic NPC patients who have failed the first-line platinum-based chemotherapy and the second-line chemotherapy.
•At least one measurable tumor lesion per RECIST 1.1 criteria. A lesion previously treated with local therapies such as radiotherapy can be considered a target lesion if there is objective evidence of progression in the lesion.
•Subjects must provide an available tumor tissue sample taken within 3 years prior to enrollment.
•Adequate organ function.

Exclusion Criteria

•Receipt of last radiotherapy or any anti-tumor treatment \[chemotherapy, targeted therapy\] within 3 weeks prior to the first dose of study treatment, Receipt of last Chinese herbal drugs with antitumor indications within 1 week prior to the first dose of study treatment.
•Prior exposure to any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways, such as ICOS or agonists (e.g. CD40, CD137, GITR and OX40 etc).
•Other invasive malignancies within 5 years, except for locally treatable (manifested as cured) malignancies, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
•Subjects with active autoimmune disease that requires systematic treatment in the past two years, 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 documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis or chronic diarrhea).
•Subjects who require systemic corticosteroids (a dose equivalent to \>10 mg/day prednisone) or other immunosuppressive drugs within 7days prior to the first dose of study drug.
•Known history of testing positive for human immunodeficiency virus (HIV).
•Known history of primary immunodeficiency virus infection.
•Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
•History of gastrointestinal perforation and/ or fistula within 6 months prior to enrollment.

Arms & Interventions

AK104 6 mg/kg

AK104 IV every 2 weeks (q2w)

Intervention: AK104

AK104 15 mg/kg

AK104 IV every 3 weeks (q3w)

Intervention: AK104

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: up to 2 years

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

Secondary Outcomes

Duration of response (DoR)(up to 2 years)
Disease control rate (DCR)(up to 2 years)
Observed concentrations of AK104(From first dose of AK104 through 90 days after last dose of AK104)
Progression-free survival (PFS)(up to 2 years)
Overall survival (OS)(up to 2 years)
Incidence of treatment-emergent adverse events (TEAEs)(From the time of informed consent signed through 90 days after last dose of AK104)
Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of AK104 through 90 days after last dose of AK104)