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Nasopharyngeal CarcinomaPhase 2NCT03848286

KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma

A Phase 2 study testing KL-A167 Injection in people with Nasopharyngeal Carcinoma and Recurrent or Metastatic, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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

The study is to evaluate the efficacy of KL-A167 injection in subjects with recurrent/metastatic Nasopharyngeal Carcinoma, as measured by Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
KL-A167 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
1 siteChina
Study dates
6 Mar 2019to 13 Jan 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥ 18 years old, male or female;
  • Subjects with histopathologically confirmed recurrent/metastatic nonkeratinizing differentiated or undifferentiated NPC;
  • Subjects with diseases of clinical stage IVB [Staging System of American Joint Committee on Cancer (AJCC) (8th edition)] who have received first line of platinum-containing combination chemotherapy and second line of monotherapy or failure of combination therapy;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
  • Expected survival ≥ 12 weeks;
  • Subjects with at least one measurable lesion according to RECIST 1.1, and lesions that have been treated with local therapies, such as radiotherapy, cannot be considered as measurable lesions;
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  • Tissue or tissue samples must be provided for biomarker analysis. Newly obtained tissues are preferred, and archived paraffin slices are acceptable for patients who do not have newly obtained tissues;
  • Adequate organ and bone marrow function, as defined below: a) Hematology: neutrophil count (NEUT #) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 90 × 10^9/L; hemoglobin concentration ≥ 9 g/dL; b) Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 5 × ULN for subjects with liver metastases; TBIL ≤ 2 × ULN for subjects with liver metastases or Gilbert's syndrome; c) Renal function: creatinine clearance (CCR) ≥ 50 mL/min; d) Coagulation function: international normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
  • Subjects who have taken chemotherapeutic drugs which should be discontinued for ≥ 4 weeks before the first dose (mitomycin or nitrosoureas should be discontinued for ≥ 6 weeks); received surgery, molecular targeted therapy, traditional Chinese medicine therapy with anti-tumor indications, radiotherapy, and anti-tumor therapy with immunostimulatory effect which should be discontinued for 4 weeks or more than 5 half-lives; and antibody drugs which should be discontinued for ≥ 12 weeks (≥ 4 weeks after discontinuation of bevacizumab or nimotuzumab is acceptable); moreover, all treatment-emergent adverse events (TEAEs, except for alopecia) should have stabilized and recovered to the level specified in the eligibility criteria or ≤ Grade 1 toxicity (NCI CTCAE V.5.0);
  • Subjects of childbearing potential (male or female) must use effective medical contraception during the study and for 6 months after the end of dosing. Women of childbearing potential must have a negative pregnancy test within 72 h before the first dose;
  • Subjects voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures.

Who cannot join

  • Subjects with locally advanced disease will not be screened if they can receive radical treatment such as surgery, radical radiotherapy, or radical chemoradiotherapy;
  • Metastases to central nervous system;
  • History of other malignancies (except for non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal cancer, breast cancer, localized prostate cancer that have been cured and have not recurred within 5 years, which are considered acceptable for enrollment by the investigator);
  • History of severe allergic diseases, history of serious drug allergy, and known allergy to macromolecular protein preparations or any component of the KL-A167 Injection formulation;
  • Prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CTLA-4 antibody, or CAR-T cells (or any other antibody acting on T-cell co-stimulation or checkpoint pathway);
  • Palliative radiotherapy (except for bone metastases) scheduled for symptom control during the study;
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  • Other systemic anti-tumor therapies that may be received during the study;
  • Prior anti-tumor vaccine within 3 months prior to the first dose;
  • Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or autologous hematopoietic stem cell transplantation within 3 months prior to the first dose;
  • Active infection, or unexplained fever before the first dose;
  • Systemic use of antibiotics within 1 week prior to signing the ICF;
  • Any active autoimmune disease or history of autoimmune disease, including, but not limited to, immune-related neurological disorders, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disorder, scleroderma, inflammatory bowel diseases including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome;
  • Subjects with hyperthyroidism and organic thyroid disease will not be screened, but those with hypothyroidism treated with a stable dose of thyroid hormone replacement therapy can be enrolled;
  • Systemic treatment with steroids (at a dose equivalent to prednisone > 10 mg/day) or other immunosuppressants within 14 days prior to the first dose; Note: Adrenaline replacement therapy at doses equivalent to prednisone ≤ 10 mg/day is allowed for subjects without active immune disease. Topical, intraocular, intra-articular, intranasal, or inhaled corticosteroids (with minimal systemic absorption) are permitted; and short-term use of corticosteroids for prophylaxis (e.g., contrast allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity caused by contact allergens) is permitted.
  • Subjects with serious medical conditions, such as cardiovascular disorders like Grade III or higher abnormal cardiac function (NYHA criteria), ischemic heart disease (such as myocardial infarction or angina pectoris), poorly controlled diabetes mellitus (fasting serum glucose ≥ 10 mmol/L), poorly controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg), and ejection fraction < 50% by echocardiography;
  • QTc interval > 450 msec for males and > 470 msec for females;
  • Abnormal ECG findings and additional risks associated with the use of the investigational product in the opinion of the investigator;
  • Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL) or hepatitis C (positive for hepatitis C antibody and HCV RNA above the lower limit of detection of the assay);
  • Known history of human immunodeficiency virus (HIV)-positive or known history of acquired immunodeficiency syndrome (AIDS);
  • Subjects with known history of interstitial pneumonia, noninfectious pneumonitis, or highly suspicious of interstitial pneumonia; or subjects with conditions that may interfere with the detection or management of suspected drug-related pulmonary toxicity; and asymptomatic subjects with prior drug-induced or radiation noninfectious pneumonitis are allowed to be enrolled;
  • Active pulmonary tuberculosis, or previous history of tuberculosis infection but not controlled by treatment;
  • Subjects who have received immunotherapy and experienced ≥ Grade 3 immune-related adverse reactions (ADRs);
  • Use of any active vaccine against infectious diseases (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to the first dose or planned to be used during the study;
  • Previous confirmed history of neurological or mental disorders, including epilepsy or dementia;
  • History of definite drug abuse or alcohol abuse within 3 months;
  • Pregnant or lactating women;
  • Participation in other clinical trials within 1 month prior to the first dose;
  • Other factors that may affect the efficacy or safety evaluation of this study in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: A Phase 2 Clinical Study To Evaluate the Efficacy and Safety of KL-A167 Injection in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

The study is to evaluate the efficacy of KL-A167 injection in subjects with recurrent/metastatic Nasopharyngeal Carcinoma, as measured by Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

Read the detailed description

KL167-Ⅱ-05-CTP (NCT03848286) is a single-arm, open-label, multicenter, phase II study of KL-A167 in pts with R/M NPC. Eligible pts were diagnosed with histopathologically confirmed R/M nonkeratinizing NPC and had received ≥ two lines of chemotherapy. Pts received 900 mg KL-A167 every 2 weeks until disease progression, intolerable toxicity, or withdrawal of consent. The primary endpoint was overall response rate (ORR) evaluated by the independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors Version 1.1.

Being tested
KL-A167 Injection
Keywords
Nasopharyngeal Carcinoma
Medical subject headings
Nasopharyngeal Carcinoma, Recurrence, Neoplasm Metastasis

What participants receive

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

  • KL-A167 InjectionDrug

    KL-A167 900 mg intravenously (IV) every-2-weeks (Q2W)

Study groups in NCT03848286
Study groupRoleWhat they receive
ExperimentalExperimentalKL-A167 900 mg intravenously (IV) every-2-weeks (Q2W)
Receives: Drug: KL-A167 Injection

What is being measured

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

  1. Objective Response Rate (ORR) assess by Independent Review Committee (IRC)

    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

    Measured: from first patient first visit to 12 month after last patient first dose

Secondary outcomes (6)

  1. ORR assess by investigators

    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and Immune-related Response Evaluation Criteria In Solid Tumors 1.1 (irRECIST 1.1)

    Measured: from first patient first visit to 12 month after last patient first dose

  2. Progression-Free Survival (PFS)

    PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

    Measured: from first patient first visit to 12 month after last patient first dose

  3. Overall Survival (OS)

    Overall Survival is defined as the time from registration to death due to any cause, or censored at date last known alive

    Measured: from first patient first visit to 12 month after last patient first dose

  4. Disease Control Rate (DCR)

    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

    Measured: from first patient first visit to 12 month after last patient first dose

  5. Duration of Response (DOR)

    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

    Measured: from first patient first visit to 12 month after last patient first dose

  6. Time to Response(TTR)

    From the date of the first dose of KL-A167 to the time the response criteria are first met

    Measured: from first patient first visit to 12 month after last patient first dose

Timeline

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

  1. First posted20 Feb 2019
  2. Study start6 Mar 2019
  3. Primary completion13 Jul 2021
  4. Study completion13 Jan 2022

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
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03848286
Sponsor's protocol ID
KL167-Ⅱ-05-CTP
Status last verified
Apr 2026
First submitted
12 Feb 2019
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Min Y, Liu X, Wei Z, Song G, Li Y, Gao K, Liu Z, Pei Y, Li H, Ge J, Qing Y, Wei Y, Peng X. Lung immune prognostic index is associated with clinical outcomes in recurrent or metastatic (R/M) nasopharyngeal carcinoma receiving immunotherapy: Results from the multicenter, single-arm, phase 2 study. Oral Oncol. 2024 Dec;159:107028. doi: 10.1016/j.oraloncology.2024.107028. Epub 2024 Sep 18.

    PubMed 39298831

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KL-A167 Injection in people with Nasopharyngeal Carcinoma and Recurrent or Metastatic, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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 11 inclusion and 28 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 5 May 2026. 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) assess by Independent Review Committee (IRC) (time frame: from first patient first visit to 12 month after last patient first dose). 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 NCT03848286, 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 5 May 2026.

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