Nasopharyngeal CarcinomaPhase 3NCT05294172

KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

A Phase 3 study testing KL-A167, Gemcitabine and Cisplatin in people with Nasopharyngeal Carcinoma and Recurrent or Metastatic, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The study is to evaluate the efficacy of KL-A167 combined with cisplatin and gemcitabine vs placebo combined with cisplatin and gemcitabine in the treatment of recurrent or metastatic nasopharyngeal carcinoma, as measured by progression-free survival (PFS) per the Response Evaluation Criteria in Solid Tumors RECIST… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Nasopharyngeal Carcinoma, Recurrent or Metastatic
What is being tested?: KL-A167, Gemcitabine and Cisplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 295 participants
Where: 1 siteChina
Study dates: 7 Jun 2022to Dec 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

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

The ages at the time of signing the informed consent are ≥ 18 years old and ≤ 75 years old, regardless of gender.
Patients with nasopharyngeal carcinoma diagnosed definitively by histology or cytology.
Recurrent or metastatic nasopharyngeal carcinoma:Nasopharyngeal carcinoma patients with distant metastasis at the time of initial diagnosis (stage IVB nasopharyngeal carcinoma as defined by the 8th Edition of the staging system of Union for International Cancer Control and American Cancer Joint Committee); or nasopharyngeal carcinoma patients with local recurrence and/or distant metastasis more than 6 months after the end of previous radical treatment.Have not received systematic treatment for recurrent or metastatic nasopharyngeal carcinoma before; those who have local recurrence are not suitable for local treatment or have been treated locally.
Eastern Cooperative Oncology Group (ECOG) performance status is 0 ~ 1 score, and the expected survival time is ≥ 12 weeks.
At least one measurable lesion according to RECIST 1.1; the lesions that have received radiotherapy are not selected as target lesions.
Patients must provide tissues or tissue specimens for biomarker analysis during the screening period, and the freshly obtained tissues are preferred. Patients who cannot obtain the fresh tissues can provide archived paraffin sections.

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Significant organ functions meet the following requirements:a)Blood routine: Neutrophil count (NEUT) ≥ 1.5×109/L; platelet count (PLT)≥100×109/L; hemoglobin ≥ 90 g/L.b)Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal value (ULN); total bilirubin (TBIL) ≤ 1.5×ULN; for patients with liver metastasis, ALT and AST ≤ 5×ULN; for patients with liver metastasis or Gilbert syndrome, TBIL ≤ 3×ULN.c)Albumin ≥ 30 g/L.d)Renal function: creatinine clearance rate (CrCl) ≥ 60 ml/min (using standard Cockcroft-Gault formula).e)Coagulation function: International standardized ratio (INR) ≤ 1.5×ULN; activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
Those who have child-bearing potential during the study period and within 6 months after the end of the last dose study (both men and women) must take effective medical contraceptive measures.
Patients voluntarily participate in this study, sign informed consent, and are able to comply with the visits and related procedures specified in the protocol.

Who cannot join

Patients with pathologically diagnosed nasopharyngeal adenocarcinoma or sarcoma.
Central nervous system metastasis is present at the time of screening.
Uncontrollable tumor-related pain.
Other malignant tumors before randomization (except those who have non-melanoma in situ skin cancer, superficial bladder cancer, cervical cancer in situ, breast cancer, localized prostate cancer, etc., which have been cured and not recurred within 3 years, and the investigator considers those who can be enrolled).
It is known that there is a history of allergy to any ingredient of KL-A167 injection or severe hypersensitivity to other monoclonal antibodies, or hypersensitivity to gemcitabine, cisplatin and any excipients.
Have received any of the following treatment:a)Previous immunotherapy, including immune checkpoint inhibitors (such as PD-1 antibody, PD-L1 antibody, CTLA-4 antibody, etc.), immune checkpoint agonists, immune cell therapy and other treatments targeting at the immune mechanism of tumor.b)Any clinical study drugs within 4 weeks before randomization.c)Participation in another clinical study concurrently, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up.d)The last dose of non-systemic anticancer therapy (including local radiotherapy, radiofrequency ablation, anti-tumor Chinese patent medicine, etc.) within 2 weeks before randomization.e)Those who were vaccinated with anti-tumor vaccine previously or have been vaccinated with any active vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before randomization or plan to do so during the study period.f)Major surgery (except diagnosis of nasopharyngeal carcinoma) or severe trauma was performed within 4 weeks before randomization.g)Any blood components, anemia correcting drugs (including but not limited to drugs which supplement hematopoietic raw materials, raise red blood cells and raise hemoglobin), drugs which raise white blood cells and platelets were used within 2 weeks before randomization.

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Concomitant diseases that may affect protocol compliance or trial results, including:a)Major cardiovascular diseases, such as Grade II and above cardiac dysfunction (NYHA standard); myocardial infarction, unstable arrhythmia or unstable angina pectoris within 3 months before randomization; previous history of myocarditis or cardiomyopathy; echocardiography showed ejection fraction < 50%; QTc interval, male > 450 msec, female > 470 msec; ECG examination is abnormal and the investigator considers there is additional risk.b) Symptomatic hypercalcemia (serum calcium> 2.9 mmol/L ).
The toxicity of previous anti-tumor treatment has not recovered to ≤ CTCAE version 5.0 Level 1 or the level specified in the inclusion/exclusion criteria (except for hair loss, fatigue, sequelae of neurotoxicity related to previous platinum treatment, specific laboratory investigation abnormalities and other conditions that the investigator judges there is no safety risk).
The history of allogeneic organ transplantation or hematopoietic stem cell transplantation is known.
Severe chronic or active infections (including active tuberculosis, etc.) occurred within 2 weeks before randomization, which required systemic antibiotics or antiviral treatment.
Any patient with active autoimmune disease or a history of autoimmune disease and possible recurrence, including but not limited to neurological diseases related to immunity, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel diseases including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome.Note: Patients with the following diseases are not excluded, and can be screened following other inclusion and exclusion criteria:a)Type 1 diabetes that can be controlled by stable dose of insulin.b)Hypothyroidism that can be controlled by hormone replacement therapy alone.c)Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, hair loss).d)Any other disease that is not expected to recur in the absence of external triggers.
Treated with systemic immuno-agonists (including but not limited to interferon or IL-2) or received systemic treatment with steroid hormones (equivalent to prednisone > 10 mg/day) or other immunosuppressants within 2 weeks before randomization.Note: Subjects without active immune diseases are allowed to receive steroid hormone replacement therapy with a dose equivalent to prednisone ≤ 10 mg/day. Topical, intraocular, intra-articular, intranasal or inhaled corticosteroids (extremely low systemic absorption) are allowed; short-term use of corticosteroids is allowed to prevent (such as allergy to contrast media) or treat non-autoimmune conditions (such as delayed type hypersensitivity caused by exposure to allergens).
Patients have active hepatitis B (HBsAg positive, but if HBV DNA detected by each study site ≤ 1×103 copy number/ml or lower than the lower limit of reference value, patients are allowed to be enrolled) or hepatitis C (hepatitis C antibody positive, but if HCV RNA lower than the lower limit of detection method, patients are allowed to be enrolled).
The history of positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) is known.
For patients with known history of interstitial lung disease (such as idiopathic pulmonary fibrosis, sarcoidosis, etc.) and non-infectious pneumonia (such as intensified pneumonia, idiopathic pneumonia, etc.), those who had drug-induced or radiation-induced rather than infectious pneumonia but were asymptomatic are allowed to be enrolled in the group.
Grade 2 or above peripheral nerve disease , defined according to CTCAE 5.0 standard.
Pregnant or lactating women.
Other clinically significant underlying diseases that may affect drug administration and protocol compliance (such as poorly controlled diabetes/hypertension, pleural effusion/pericardial effusion/ascites requiring repeated drainage, drug or alcohol abuse, etc.) considered by the investigator, as well as other factors that may affect the efficacy or safety assessment of this study.

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: KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial

Read the detailed description

This study is a randomized, double-blind, placebo-controlled and multicenter study. It is expected that patients with recurrent or metastatic nasopharyngeal carcinoma who had not received systematic anti-tumor treatment before are enrolled, and the efficacy and safety of KL-A167 injection combined with cisplatin and gemcitabine are compared with placebo combined with cisplatin and gemcitabine in the treatment of recurrent or metastatic nasopharyngeal carcinoma. Subjects who meet the enrollment requirements will be randomized to the trial group or the control group according to the ratio of 2:1. The stratification factors are: liver metastasis (with vs without) and ECOG score (0 vs 1)

Conditions: Nasopharyngeal Carcinoma, Recurrent or Metastatic
Being tested: KL-A167, Gemcitabine, Cisplatin, Placebo
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-A167Drug
KL-A167 4-6 cycles for combined therapy.KL-A167 maintenance.
GemcitabineDrug
Also called Gemcitabine Hydrochloride for Injection
4-6 cycles for combined therapy
CisplatinDrug
Also called Cisplatin injection
4-6 cycles for combined therapy.
PlaceboDrug
4-6 cycles for combined therapy.Placebo maintenance.

Study groups in NCT05294172
Study group	Role	What they receive
KL-A167+Gemcitabine+Cisplatin	Experimental	subject will receive KL-A167 1200mg every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, 4-6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day,4-6 cycles Receives: Drug: KL-A167; Drug: Gemcitabine; Drug: Cisplatin
Placebo+Gemcitabine+Cisplatin	Placebo comparator	subject will receive placebo every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, 4-6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, 4-6 cycles Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Placebo

What is being measured

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

Progression-free survival (PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee according to RECIST v1.1 or death from any cause, whichever occurs first
Measured: up to 24 month

Secondary outcomes (7)

Progression-free survival(PFS)
Progression-free survival (PFS) assessed by the investigators according to RECIST V 1.1
Measured: up to 24 month
Objective Response Rate (ORR)
The percentage of patients with CR and PR assessed by the Independent Review Committee and investigators according to RECIST v 1.1
Measured: up to 24 month
Disease Control Rate (DCR)
The proportion of patients who have achieved CR，PR and SD assessed by the Independent Review Committee and investigators according to RECIST v 1.1
Measured: up to 24 month
Duration of Response (DoR)
From the date that response criteria are first met to the first occurrence of PD as determined by the Independent Review Committee and investigators according to RECIST v1.1 or death from any cause, whichever occurs first
Measured: up to 24 month
Overall Survival (OS)
OS, defined as the time from randomization to death or lose of follow, whichever occurs first
Measured: up to 24 month
1 year and 2 years Overall Survival (OS) rate
The percentage of patients overall survival in 1 year and 2 years
Measured: up to 24 month
Time to Response（TTR）
The time from randomization to the date that response criteria are first met assessed by the Independent Review Committee and investigators according to RECIST v 1.1
Measured: up to 24 month

Timeline

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

7 Jun 2022Dec 2027

First posted24 Mar 2022
Study start7 Jun 2022
Primary completionDec 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
More trials run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: multicenter, double-blind, randomized, controlled phase III trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 295 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05294172
Sponsor's protocol ID: KL-A167-III-08
Status last verified: May 2026
First submitted: 15 Mar 2022
Last updated: 8 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nasopharyngeal Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial
ClinicalTrials.gov ID: NCT05294172
Acronym / sponsor ID: KL-A167-III-08
Conditions: Nasopharyngeal Carcinoma, Recurrent or Metastatic
Keywords: Nasopharyngeal Carcinoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 295 participants (actual)
Lead sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 7 Jun 2022 (actual)
Primary completion: Dec 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 24 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: multicenter, double-blind, randomized, controlled phase III trial

Arm	Type	Receives
KL-A167+Gemcitabine+Cisplatin	Experimental	Drug: KL-A167, Drug: Gemcitabine, Drug: Cisplatinsubject will receive KL-A167 1200mg every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, 4-6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day,4-6 cycles
Placebo+Gemcitabine+Cisplatin	Placebo comparator	Drug: Gemcitabine, Drug: Cisplatin, Drug: Placebosubject will receive placebo every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, 4-6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, 4-6 cycles

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

The ages at the time of signing the informed consent are ≥ 18 years old and ≤ 75 years old, regardless of gender.
Patients with nasopharyngeal carcinoma diagnosed definitively by histology or cytology.
Recurrent or metastatic nasopharyngeal carcinoma:Nasopharyngeal carcinoma patients with distant metastasis at the time of initial diagnosis (stage IVB nasopharyngeal carcinoma as defined by the 8th Edition of the staging system of Union for International Cancer Control and American Cancer Joint Committee); or nasopharyngeal carcinoma patients with local recurrence and/or distant metastasis more than 6 months after the end of previous radical treatment.Have not received systematic treatment for recurrent or metastatic nasopharyngeal carcinoma before; those who have local recurrence are not suitable for local treatment or have been treated locally.
Eastern Cooperative Oncology Group (ECOG) performance status is 0 ~ 1 score, and the expected survival time is ≥ 12 weeks.
At least one measurable lesion according to RECIST 1.1; the lesions that have received radiotherapy are not selected as target lesions.

Key exclusion criteria (18 listed)

Patients with pathologically diagnosed nasopharyngeal adenocarcinoma or sarcoma.
Central nervous system metastasis is present at the time of screening.
Uncontrollable tumor-related pain.
Other malignant tumors before randomization (except those who have non-melanoma in situ skin cancer, superficial bladder cancer, cervical cancer in situ, breast cancer, localized prostate cancer, etc., which have been cured and not recurred within 3 years, and the investigator considers those who can be enrolled).
It is known that there is a history of allergy to any ingredient of KL-A167 injection or severe hypersensitivity to other monoclonal antibodies, or hypersensitivity to gemcitabine, cisplatin and any excipients.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KL-A167KL-A167 4-6 cycles for combined therapy.KL-A167 maintenance.	Drug	KL-A167+Gemcitabine+Cisplatin
GemcitabineAlso: Gemcitabine Hydrochloride for Injection4-6 cycles for combined therapy	Drug	KL-A167+Gemcitabine+Cisplatin, Placebo+Gemcitabine+Cisplatin
CisplatinAlso: Cisplatin injection4-6 cycles for combined therapy.	Drug	KL-A167+Gemcitabine+Cisplatin, Placebo+Gemcitabine+Cisplatin
Placebo4-6 cycles for combined therapy.Placebo maintenance.	Drug	Placebo+Gemcitabine+Cisplatin

Primary outcome

Progression-free survival (PFS)
Time frame: up to 24 month
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee according to RECIST v1.1 or death from any cause, whichever occurs first

7 secondary outcomes

Progression-free survival(PFS)
Time frame: up to 24 month
Objective Response Rate (ORR)
Time frame: up to 24 month
Disease Control Rate (DCR)
Time frame: up to 24 month
Duration of Response (DoR)
Time frame: up to 24 month
Overall Survival (OS)
Time frame: up to 24 month
1 year and 2 years Overall Survival (OS) rate
Time frame: up to 24 month
Time to Response（TTR）
Time frame: up to 24 month

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Individual participant dataSharing planned: No

Related trials for Nasopharyngeal Carcinoma

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 8 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Progression-free survival (PFS) (time frame: up to 24 month). 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 NCT05294172.

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 8 May 2026.