Advanced Nasopharyngeal CarcinomaPhase 1NCT05751486

A Clinical Study to Evaluate the Safety and Tolerability of JS001sc in Advanced Nasopharyngeal Carcinoma

A Phase 1 study testing Toripalimab injection(subcutaneous)/JS001sc and Toripalimab /JS001 in people with Advanced Nasopharyngeal Carcinoma, run by Shanghai Junshi Bioscience 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 purpose of this phase I clinical study was to evaluate the safety and tolerability of JS001sc monotherapy and combination with gemcitabine and cisplatin (GP) in patients with Advanced nasopharyngeal carcinoma. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Nasopharyngeal Carcinoma
What is being tested?: Toripalimab injection(subcutaneous)/JS001sc and Toripalimab /JS001
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteChina
Study dates: 16 Nov 2022to 31 Oct 2024
Phase: Phase 1
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

The subjects voluntarily participated in the study with full informed consent and signed written informed consent form;
Recurrent/metastatic nasopharyngeal carcinoma diagnosed histologically and/or cytologically,Patients with no loco-regional therapy or radical therapy of primary metastatic （UICC\&AJCC 8th edition) or recurrent nasopharyngeal carcinoma after radical therapy.No previous systematic treatment for recurrent or metastatic disease.
Patients with recurrent nasopharyngeal carcinoma after radical therapy must be satisfied that the disease recurrence more than 6 months after the last radiotherapy or chemotherapy.
There should be at least one measurable lesion according to RECIST V1.1 evaluation criteria. The lesions that have previously received radiotherapy should not be considered as target lesions unless there is definite progression after radiotherapy.
Age of 18-75 years (inclusive), male or female;
The physical status score is 0 or 1 on the Eastern Oncology Collaboration (ECOG) scale;

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The expected survival is ≥3 months;
Major organ functions meet the following requirements.No blood transfusion or blood products, hematopoietic stimulating factors or other drugs were used to correct blood cell counts within 14 days prior to the examination：
Neutrophil absolute count ≥1.5 × 109/L;
Platelet count ≥ 100 × 109/L;
Hemoglobin ≥ 90 g/L;
Serum albumin ≥ 30 g/L;
Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) with biliary obstruction resolved prior to randomization;
Alkaline phosphatase (ALP)≤ 3 × ULN, ALP≤ 5 × ULN (Patients may have liver or bone metastasis);
Albumin ≥ 30 g/L;
Serum creatinine (Cr) ≤ 1.5 × ULN, Cr clearance ≥ 60 mL/min (Cockcroft -Gault Formulas, refer to attachment 2);
International Normalized Ratio (INR), prothrombin time (PT), and activated Partial thrombin Time (aPTT) ≤ 1.5× ULN (Patients should not have received anticoagulant therapy);If Patients receiving anticoagulant therapy that they should use a steady dose;
Within 7 days prior to the first dose, women of reproductive age must be confirmed as having a negative serum pregnancy test and consent to use effective contraception during the duration of study drug use and for 150 days after the last dose. Women of childbearing age are defined as sexually mature women: 1) no hysterectomy or bilateral ovariectomy, 2) Natural menopause did not last for 24 consecutive months (Amenorrhea after cancer treatment does not rule out fertility);Male patients with a female partner of reproductive age agreed to use effective contraception during the study drug use period and for 6 months after the last dose;

Who cannot join

A history of severe allergic reactions to to any component of JS001;
A history of hypersensitivity to gemcitabine or cisplatin or any excipients;
Prior treatment with Anti-PD-1 antibody, anti-PD-L1 or anti-CTLA-4 antibody;
Received antitumor therapy ,Such as, chemotherapy, radiotherapy,immune therapy therapy, biological drugs therapy or other investigational drugs within 4 weeks or 5 half-lives period （Choose the shorter one）before the administration of the first dose;Receive traditional Chinese medicine or Chinese patent medicine preparations with anti-tumor indications within 2 weeks prior to initial administration;
Within 28 days prior to the first study drug administration, there are other major surgeries except for the diagnosis of nasopharynx carcinoma, or assessed by researchers and specialists that they did not have fully recovered from the complications of major surgery;
The toxic response of previous anti-tumor treatment has not been restored to CTCAE 0-1, except for hair loss and pigmentation.Irreversible toxicity reasonably expected not to be aggravated by the drug under study (e.g. hearing loss). They can be included after confirmation with the sponsor.

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A subject with clinical symptoms of CNS and/or cancer meningitis (such as cerebral edema, hormone intervention, or brain metastases) No clear surgery and/or radiotherapy for spinal cord compression, or for spinal cord compression that previously diagnosed and treated, no evidence indicates that the first study of pre -dating diseases in clinical stability ≥2 weeks of clinical clinic; Received the treatment of brain or meningeral membrane, such as clinical stability has been maintained for at least 2 months, and has stopped systemic hormone therapy (dose> 10 mg/day dawnone or other curative hormones such as);
Poorly controlled the thoracic effusion, pericardial effusion, or ascites that need to be drained (thoracic ascites ≥1 times/month)
Poorly controlled tumor-related pain:
For patients who need analgesic treatment, they must receive a stable dose treatment before participating in the study ; Before entering the group, a clinical indication lesions should be treated for local treatment (for example, bone metastases or metastasis of neurotransidal);
Featured pulmonary fibrosis, drug -induced pneumonia, mechanized pneumonia (that is, occlusion fine pineitis), radioactive pneumonia with clinical symptoms or steroids, active pneumonia or other medium -weight lungs that seriously affect lung function that seriously affect lung function disease;
The first 4 weeks before the medication found that there were necrotic lesions, and the researchers judged that there was a risk of hemorrhage;
Within the first 5 years of administration, there are other malignant tumors other than nasopharyngeal cancer (except for cured cervical in situ cancer, base or squamous cell skin cancer, limited prostate cancer or Ductal carcinoma in situ of breast);
The subject has any active autoimmune disease or a history of autoimmune diseases within two years. Except for the following situations: 1) patients with thyroid dysfunction, receiving stable dose thyroid hormone replacement treatment; 2) receiving stable insulin therapy schemes Later, patients with type I diabetes were obtained; 3) skin diseases that do not need to be treated with whole body, such as psoriasis, vitiligo, etc. (for more comprehensive list of autoimmune diseases, see Annex 4);
Severe infections (CTCAE> 2) within 28 days before the administration (CTCAE> 2), such as severe pneumonia, fungal ledis, infection complications, etc. that need to be hospitalized;
Availability with active lung tuberculosis (TB) is undergoing anti -tuberculosis treatment or screening within one year before receiving anti -tuberculosis treatment;
It suffers from corticosteroids that require long -term use of immunosuppressive drug treatment, or the use of immunosuppressive dose (dose> 10 mg/day or other curative hormones such as 10 mg/day);
Received any live vaccine within 4 weeks before the medication (for example, vaccines for infectious diseases, such as influenza vaccines, chickenpox vaccines, etc.);
Women of pregnancy or lactation;
Known human immune defect virus (HIV) positive patients;
Hepatitis B core antibodies (HBCAB) or hepatitis B surface antigen (HBSAG) positive detection of HBV DNA copy number ≥1000CPS/ml or reference value limit;
Hepatitis C (HCV) antibody positive at the same time detected HCV RNA copies of positive;
Patients who have been transplanted in the same kind of album bone marrow or previously performed physical organ transplantation;
There are severe nerve or mental illness, including dementia and seizures;
Due to NCI-CTCAE ≥ 2 peripheral neuropathy;
With major cardiovascular diseases, such as the New York Heart Diseases (NYHA) heart function grading II or above heart disease (see Annex 3), the myocardial infarction and control within 3 months before the first study; Unstable angina pectoris; Knitrines of patients with coronary arteries, congestive heart failure of the above standards, or left ventricular ejection scores <50%of patients must use the optimized stable medical plan determined by the doctor. If appropriate, you can consult the heart. Sick expert;
Investigators are judged that they are not suitable for other situations in this study, including but not limited to any disease or medical history that may confuse the results o study and interfere with patients.

Trial locations and contacts

1 site in 1 country.

China1 site

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Randomised, Open-label, Phase I Dose Exploration Study to Compare Single, Multiple, and Long-term Dosing of Toripalimab Injection (Subcutaneous) With Toripalimab Injection (IV) in Patients With Advanced Nasopharyngeal Carcinoma

Read the detailed description

This study is the first human study of Toripalimab injection(subcutaneous) .Patients with advanced nasopharyngeal carcinoma were planned to be enrolled.

Two cohorts were initially proposed, Toripalimab injection (subcutaneous) Q3W combination with gemcitabine and cisplatin (GP) regimen and JS001sc long-term dosing combined with GP regimen.

Cohort 1: JS001sc Q3W SC combined with GP regimen chemotherapy; Cohort 2: JS001sc long period SC combined with GP regimen chemotherapy; IV cohort (if applicable): the Safety Monitor Committe (SMC) will discuss whether to conduct an IV cohort and determine the dose/frequency of the IV cohort, based on the initial safety and clinical pharmacological data of triprilimab injection in combination with the GP regimen; Additional cohort (if applicable): the exploration of additional dosing/frequency will be discussed by the SMC based on prior safety and clinical pharmacological data.

Subjects with no disease progression (PD) after the combination chemotherapy period (JS001/JS001SC combined with GP regimen, in one therapeutic cycle of three weeks, for at most 6 cycles) will enter the monotherapy maintenance period.JS001/JS001sc monotherapy maintenance treatment of the same dose/frequency f the combination chemotherapy period.Based on the preliminary safety and clinical pharmacological data, SMC will discusses whether to change the dose/frequency.

Conditions: Advanced Nasopharyngeal Carcinoma
Being tested: Toripalimab injection(subcutaneous)/JS001sc, Toripalimab /JS001

What participants receive

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

Toripalimab injection(subcutaneous)/JS001scBiological
JS001sc Q3W combination with gemcitabine and cisplatin.
Toripalimab injection(subcutaneous)/JS001scBiological
JS001sc long period combination with gemcitabine and cisplatin.
Toripalimab /JS001Biological
JS001 IV (if applicable) .
Toripalimab injection(subcutaneous)/JS001scBiological
Additional cohort (if applicable)

Study groups in NCT05751486
Study group	Role	What they receive
JS001sc Q3W	Experimental	Not described Receives: Biological: Toripalimab injection(subcutaneous)/JS001sc
JS001sc long period	Experimental	Not described Receives: Biological: Toripalimab injection(subcutaneous)/JS001sc
JS001 IV (if applicable)	Experimental	the Safety Monitor Committe (SMC) will discuss whether to conduct an IV cohort and determine the dose/frequency of the IV cohort, based on the initial safety and clinical pharmacological data of triprilimab injection in combination with the GP regimen; Receives: Biological: Toripalimab /JS001
Additional cohort (if applicable)	Experimental	The exploration of additional dosing/frequency will be discussed by the SMC based on prior safety and clinical pharmacological data Receives: Biological: Toripalimab injection(subcutaneous)/JS001sc

What is being measured

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

Cmax
Maximum observed serum concentration
Measured: At designated time points (Approximately 2 years)
Tmax
Time of maximum observed serum concentration
Measured: At designated time points (Approximately 2 years)
AUC
Area Under the Concentration-Time Curve
Measured: At designated time points (Approximately 2 years)
CL
Clearance
Measured: At designated time points (Approximately 2 years)
Volume of Distribution
V
Measured: At designated time points (Approximately 2 years)
F
Bioavailability
Measured: At designated time points (Approximately 2 years)
Ctrough
Trough observed serum toripalimab concentration
Measured: At designated time points (Approximately 2 years)

Secondary outcomes (3)

Immunogenicity
Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (Nab), titer of ADA positive samples
Measured: Up to approximately 24 months from first patient in.
adverse events (AE), immune-related adverse events (irAE) and serious adverse events (SAE)
To evaluate incidence, severity and outcome of adverse events (AE), immune-related adverse events (irAE) and serious adverse events (SAE)
Measured: Until 2 years after the last subject was enrolled
ORR
Objective response rate (ORR) was assessed based on RECIST V1.1 criteria
Measured: Up to approximately 24 months from first patient in.

Timeline

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

16 Nov 202231 Oct 2024

First posted2 Mar 2023
Study start16 Nov 2022
Primary completion30 Dec 2023
Study completion31 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Parallel
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05751486
Sponsor's protocol ID: JS001sc-001-I
Status last verified: Jul 2026
First submitted: 21 Feb 2023
Last updated: 7 Jul 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 Advanced Nasopharyngeal Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Open-label, Phase I Dose Exploration Study to Compare Single, Multiple, and Long-term Dosing of Toripalimab Injection (Subcutaneous) With Toripalimab Injection (IV) in Patients With Advanced Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT05751486
Acronym / sponsor ID: JS001sc-001-I
Conditions: Advanced Nasopharyngeal Carcinoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
Study start: 16 Nov 2022 (actual)
Primary completion: 30 Dec 2023 (actual)
Study completion: 31 Oct 2024 (actual)
First posted: 2 Mar 2023 (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

This study is the first human study of Toripalimab injection(subcutaneous) .Patients with advanced nasopharyngeal carcinoma were planned to be enrolled.

Two cohorts were initially proposed, Toripalimab injection (subcutaneous) Q3W combination with gemcitabine and cisplatin (GP) regimen and JS001sc long-term dosing combined with GP regimen.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: Parallel

Arm	Type	Receives
JS001sc Q3W	Experimental	Biological: Toripalimab injection(subcutaneous)/JS001sc
JS001sc long period	Experimental	Biological: Toripalimab injection(subcutaneous)/JS001sc
JS001 IV (if applicable)	Experimental	Biological: Toripalimab /JS001the Safety Monitor Committe (SMC) will discuss whether to conduct an IV cohort and determine the dose/frequency of the IV cohort, based on the initial safety and clinical pharmacological data of triprilimab injection in combination with the GP regimen;
Additional cohort (if applicable)	Experimental	Biological: Toripalimab injection(subcutaneous)/JS001scThe exploration of additional dosing/frequency will be discussed by the SMC based on prior safety and clinical pharmacological data

Who may qualify

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

Key inclusion criteria (18 listed)

The subjects voluntarily participated in the study with full informed consent and signed written informed consent form;
Recurrent/metastatic nasopharyngeal carcinoma diagnosed histologically and/or cytologically,Patients with no loco-regional therapy or radical therapy of primary metastatic （UICC\&AJCC 8th edition) or recurrent nasopharyngeal carcinoma after radical therapy.No previous systematic treatment for recurrent or metastatic disease.
Patients with recurrent nasopharyngeal carcinoma after radical therapy must be satisfied that the disease recurrence more than 6 months after the last radiotherapy or chemotherapy.
There should be at least one measurable lesion according to RECIST V1.1 evaluation criteria. The lesions that have previously received radiotherapy should not be considered as target lesions unless there is definite progression after radiotherapy.
Age of 18-75 years (inclusive), male or female;

Key exclusion criteria (27 listed)

A history of severe allergic reactions to to any component of JS001;
A history of hypersensitivity to gemcitabine or cisplatin or any excipients;
Prior treatment with Anti-PD-1 antibody, anti-PD-L1 or anti-CTLA-4 antibody;
Received antitumor therapy ,Such as, chemotherapy, radiotherapy,immune therapy therapy, biological drugs therapy or other investigational drugs within 4 weeks or 5 half-lives period （Choose the shorter one）before the administration of the first dose;Receive traditional Chinese medicine or Chinese patent medicine preparations with anti-tumor indications within 2 weeks prior to initial administration;
Within 28 days prior to the first study drug administration, there are other major surgeries except for the diagnosis of nasopharynx carcinoma, or assessed by researchers and specialists that they did not have fully recovered from the complications of major surgery;

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
Toripalimab injection(subcutaneous)/JS001scJS001sc Q3W combination with gemcitabine and cisplatin.	Biological	JS001sc Q3W
Toripalimab injection(subcutaneous)/JS001scJS001sc long period combination with gemcitabine and cisplatin.	Biological	JS001sc long period
Toripalimab /JS001JS001 IV (if applicable) .	Biological	JS001 IV (if applicable)
Toripalimab injection(subcutaneous)/JS001scAdditional cohort (if applicable)	Biological	Additional cohort (if applicable)

Primary outcome

Cmax
Time frame: At designated time points (Approximately 2 years)
Maximum observed serum concentration
Tmax
Time frame: At designated time points (Approximately 2 years)
Time of maximum observed serum concentration
AUC
Time frame: At designated time points (Approximately 2 years)
Area Under the Concentration-Time Curve
CL
Time frame: At designated time points (Approximately 2 years)
Clearance
Volume of Distribution
Time frame: At designated time points (Approximately 2 years)
V
F
Time frame: At designated time points (Approximately 2 years)
Bioavailability
Ctrough
Time frame: At designated time points (Approximately 2 years)
Trough observed serum toripalimab concentration

3 secondary outcomes

Immunogenicity
Time frame: Up to approximately 24 months from first patient in.
adverse events (AE), immune-related adverse events (irAE) and serious adverse events (SAE)
Time frame: Until 2 years after the last subject was enrolled
ORR
Time frame: Up to approximately 24 months from first patient in.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
Individual participant dataSharing planned: No

Related trials for Advanced Nasopharyngeal Carcinoma

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P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
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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 18 inclusion and 27 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 7 Jul 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Cmax (time frame: At designated time points (Approximately 2 years)). The study lists 7 primary outcomes in all. 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 NCT05751486.

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 7 Jul 2026.