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Nasopharyngeal CarcinomaPhase 2NCT04220307

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

A Phase 2 study testing AK104 in people with Nasopharyngeal Carcinoma, run by Akeso at 1 site 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 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). 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?
AK104
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
26 Apr 2020to 9 Mar 2023
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] 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.
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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 1000 IU/ mL or active hepatitis C virus (HCV) should be excluded. Subjects with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA <1000 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, 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 v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria, with the exception of alopecia.
  • Receipt of live attenuated vaccination within 30 days prior to the first dose of study treatment, or plan to receive live attenuated vaccine during the study.
  • Known history of severe hypersensitivity to other monoclonal antibodies.
  • Known allergic reactions to any ingredients of AK104
  • 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

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 528403

Other trials in China

About this study

Official title: 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

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).

Being tested
AK104
Keywords
Immuno-oncology, PD-1/CTLA-4 Bispecific
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • AK104Biological

    Subjects will receive AK104 by intravenous administration

Study groups in NCT04220307
Study groupRoleWhat they receive
AK104 6 mg/kgExperimentalAK104 IV every 2 weeks (q2w)
Receives: Biological: AK104
AK104 15 mg/kgExperimentalAK104 IV every 3 weeks (q3w)
Receives: Biological: AK104

What is being measured

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

  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

    Measured: up to 2 years

Secondary outcomes (7)

  1. Progression-free survival (PFS)

    PFS is defined as the time from the date of first dosing 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)

    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)

    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 first dosing to death from any cause

    Measured: up to 2 years

  5. Incidence 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 AK104

  6. Observed concentrations of AK104

    The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration

    Measured: From first dose of AK104 through 90 days after last dose of AK104

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

    The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)

    Measured: From first dose of AK104 through 90 days after last dose of AK104

Timeline

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

  1. First posted7 Jan 2020
  2. Study start26 Apr 2020
  3. Primary completion15 May 2021
  4. Study completion9 Mar 2023

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04220307
Sponsor's protocol ID
AK104-204
Status last verified
Sep 2024
First submitted
4 Jan 2020
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK104 in people with Nasopharyngeal Carcinoma, run by Akeso at 1 site 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 25 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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) (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 NCT04220307.

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 19 Sep 2024.

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