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Nasopharyngeal CarcinomaPhase 2NCT03866967

A Study of Anti-PD-1 AK105 in Patients With Metastatic Nasopharyngeal Carcinoma

A Phase 2 study testing AK105 in people with Nasopharyngeal Carcinoma, run by Akeso at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter, single-arm open-label, phase II study to evaluate the anti-tumor activity, safety, PK and immunogenicity of AK105 (Anti-PD1 antibody) 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
AK105
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
2 sitesChina
Study dates
27 Mar 2019to 22 Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Receipt of last radiotherapy or any anti-tumor treatment [chemotherapy, targeted therapy, immunotherapy, Chinese herbal drugs with antitumor indications, or immunomodulators or tumor embolization] within 4 weeks prior to the first dose of study treatment. Nitrosourea or mitomycin C treatment within 6 weeks prior to the first dose of AK105.
  • 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 2 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, 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 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 14 days prior to the first dose of study drug.
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  • 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.
  • Subjects with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ mL or active hepatitis C virus (HCV) should be excluded. Subjects with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA <500 IU/ mL) , and cured hepatitis C can be enrolled. Subjects with positive HCV antibodies are eligible only if the HCV RNA test results are negative.
  • Major surgery (as defined by the investigator) within 30 days prior to the first dose of study drug.
  • Presence of meningeal metastasis, spinal cord compression, leptomeningeal disease, or active brain metastasis.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria, with the exception of alopecia.
  • Receipt of live or attenuated vaccination within 30 days prior to the first dose of study treatment, or plan to receive live or attenuated vaccine during the study.
  • Known history of server hypersensitivity to other monoclonal antibodies.
  • Known severe allergic reactions to paclitaxel, carboplatin, or their preventive medications.
  • Known allergic reactions to any ingredients of AK105.
  • Pregnant or lactating women.
  • Any conditions that, in the investigator's opinion, may put subjects treated with the study drug at risks, or interfere with the evaluation of study drug or subject safety, or the interpretation of study results.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • FuDan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Single-arm, Open-label, Multicenter Phase II Clinical Study of AK105 in Patients With Metastatic Nasopharyngeal Carcinoma After Failure of Second and Subsequent Lines of Chemotherapy

This is a multicenter, single-arm open-label, phase II study to evaluate the anti-tumor activity, safety, PK and immunogenicity of AK105 (Anti-PD1 antibody) 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).

Being tested
AK105
Keywords
immunotherapy, Anti-PD-1 antibody, Nasopharyngeal Carcinoma, immuno-oncology
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK105Biological

    intravenous (IV) infusion

Study groups in NCT03866967
Study groupRoleWhat they receive
AK105ExperimentalSubjects receive AK105 200 mg intravenously (IV) once every 2 weeks (Q2W) until progression.
Receives: Biological: AK105

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR) assessed by IRRC per RECIST v1.1 for anti-tumor activity in the Full Analysis Set (FAS) population

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

    Measured: up to 2 years

Secondary outcomes (9)

  1. Progression-free survival (PFS) as assessed by IRRC and investigator

    PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) or death from any cause (whichever occurs first).

    Measured: up to 2 years

  2. Disease control rate (DCR) as assessed by IRRC and investigator

    DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1.

    Measured: up to 2 years

  3. Duration of response (DoR) as assessed by IRRC and investigator

    DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: up to 2 years

  4. Overall survival (OS)

    OS is defined as the time from the date of randomization to death from any cause.

    Measured: up to 2 years

  5. Incidence and severity of treatment-emergent adverse events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence or the deterioration of existing medical event in a clinical study subject administered an investigational drug, which does not necessarily have an unequivocal causal relationship with the investigational product.

    Measured: From the time of informed consent signed through 90 days after last dose of AK105

  6. Observed concentrations of AK105

    The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration.

    Measured: From first dose of AK105 through 90 days after last dose of AK105

  7. Number of subjects who develop detectable anti-drug antibodies (ADAs)

    The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).

    Measured: From first dose of AK105 through 90 days after last dose of AK105

  8. ORR as assessed by investigator per RECIST v1.1 for anti-tumor activity in the FAS population

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

    Measured: up to 2 years

  9. Time to response (TTR) assessed by IRRC and investigator ；

    TTR is defined as the time from the first dose of study drug to the first documented response (CR or PR).

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2019
  2. Study start27 Mar 2019
  3. Primary completion13 Mar 2021
  4. Study completion22 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03866967
Sponsor's protocol ID
AK105-202
Status last verified
Feb 2025
First submitted
6 Mar 2019
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang Z, Pang X, Zhong T, Qu T, Chen N, Ma S, He X, Xia D, Wang M, Xia M, Li B. Penpulimab, an Fc-Engineered IgG1 Anti-PD-1 Antibody, With Improved Efficacy and Low Incidence of Immune-Related Adverse Events. Front Immunol. 2022 Jun 27;13:924542. doi: 10.3389/fimmu.2022.924542. eCollection 2022.

    PubMed 35833116

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK105 in people with Nasopharyngeal Carcinoma, run by Akeso at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) assessed by IRRC per RECIST v1.1 for anti-tumor activity in the Full Analysis Set (FAS) population (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03866967, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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