A Study of a PD-1/CTLA-4 Bispecific Antibody AK104 in Patients With Metastatic Nasopharyngeal Carcinoma

NCT04220307 | Completed Phase 2

• 1 other identifier: AK104-204
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Nasopharyngeal Carcinoma

Keywords

Immuno-oncology; PD-1/CTLA-4 Bispecific

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

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

  up to 2 years

Secondary Outcomes (7)

• Progression-free survival (PFS)

  up to 2 years

• Disease control rate (DCR)

  up to 2 years

• Duration of response (DoR)

  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

Study Arms (2)

AK104 6 mg/kg

EXPERIMENTAL

AK104 IV every 2 weeks (q2w)

Biological: AK104

AK104 15 mg/kg

EXPERIMENTAL

AK104 IV every 3 weeks (q3w)

Biological: AK104

Interventions

AK104 BIOLOGICAL

Subjects will receive AK104 by intravenous administration

AK104 15 mg/kg; AK104 6 mg/kg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.
• 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.
• Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception.
• 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

You may not qualify if:

• 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.
• Necrotic lesion(s) found by examinations within 4 weeks prior to enrollment, which, in the investigator's opinion, is at risk of massive bleeding.
• Known history of interstitial lung disease.
• Known history of active tuberculosis (TB).
• Serious infections within 4 weeks prior to the first dose of study drug, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia.
• An active infection requiring systemic therapy.

Sponsors & Collaborators

• Akeso: lead
• Akeso Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 528403, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Ruihua Xu, MD

  Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2020
• First Posted: January 7, 2020
• Study Start: April 26, 2020
• Primary Completion: May 15, 2021
• Study Completion: March 9, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)