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

NCT05751486 | Unknown Phase 1 DMC

• 1 other identifier: JS001sc-001-I
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (7)

• Cmax

  Maximum observed serum concentration

  At designated time points (Approximately 2 years)

• Tmax

  Time of maximum observed serum concentration

  At designated time points (Approximately 2 years)

• AUC

  Area Under the Concentration-Time Curve

  At designated time points (Approximately 2 years)

• CL

  Clearance

  At designated time points (Approximately 2 years)

• Volume of Distribution

  V

  At designated time points (Approximately 2 years)

• F

  Bioavailability

  At designated time points (Approximately 2 years)

• Ctrough

  Trough observed serum toripalimab concentration

  At designated time points (Approximately 2 years)

Secondary Outcomes (3)

• Immunogenicity

  Up to approximately 24 months from first patient in.

• adverse events (AE), immune-related adverse events (irAE) and serious adverse events (SAE)

  Until 2 years after the last subject was enrolled

• ORR

  Up to approximately 24 months from first patient in.

Study Arms (4)

JS001sc Q3W

EXPERIMENTAL

Biological: Toripalimab injection(subcutaneous)/JS001sc

JS001sc long period

EXPERIMENTAL

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;

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

Biological: Toripalimab injection(subcutaneous)/JS001sc

Interventions

Toripalimab injection(subcutaneous)/JS001sc BIOLOGICAL

JS001sc Q3W combination with gemcitabine and cisplatin.

JS001sc Q3W

Toripalimab /JS001 BIOLOGICAL

JS001 IV (if applicable) .

JS001 IV (if applicable)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

toripalimab

Central Study Contacts

Beibei Fei

CONTACT

+86 181 9214 1308; beibei_fei@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 2, 2023
• Study Start: October 21, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2025
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)