KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy

• Status: Unknown status
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Criteria

Inclusion Criteria:

• 18 years and older

• Histologically confirmed Recurrent/Metastatic Nasopharyngeal Carcinoma

• Stage IVb R/M NPC failed from first-line platinum based chemotherapy and second-line chemotherapy

• ECOG performance status of 0 or 1

• Life expectancy ≥ 12 weeks

• Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria

• Can provide either a newly obtained or archival tumor tissue sample

• Subject must have adequate organ functions and meet requirements on laboratory values.：Count of Blood Cells: absolute neutrophil count (NEUT#) ≥ 1.5 × 10^9 / L; platelet count (PLT) ≥ 90 × 10^9 / L; hemoglobin content (HGB) ≥ 9.0 g / L; Liver function: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN，with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) and patients with hepatic metastases or Gilbert's syndrome (total bilirubin ≤ 3 × ULN)；Renal function: Creatinine clearance rate（CCR）≥50 mL/min；International normalized ratio (INR) and Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN ；Thyroid function: thyroid stimulating hormone (TSH), free thyroxine（FT4）and free triiodothyronine(FT3) in normal ±10% range, hypothyroidism controlled by drug can be included, hyperthyroidism can not be included

• Prior chemotherapy, radiotherapy, immunotherapy or investigational therapy (including Chinese herbal medicine and Chinese patent medicine) used to control cancer including locoregional treatment must have been completed ≥ 4 weeks before the first dose of KL-A167(Mitomycin or nitroso must have been completed ≥ 6 weeks), antibody therapy must have been completed ≥ 12 weeks, and all treatment-related adverse events (except alopecia) are stable and have either returned to baseline or Grade 0/1

• Subjects of reproductive potential must be willing to use adequate contraception during the course of the study and through 6 months after the last dose of study medication. Female of child bearing potential, a negative serum pregnancy test result within 72 h before study treatment

• Subject has voluntarily agreed to participate by giving written informed consent

Exclusion Criteria:

• Subject of locally advanced can receive radical treatment such as surgery, radical radiotherapy or radical chemotherapy, can not be included

• Subjects having metastases to central nervous system

• Has a known additional malignancy before study treatment with the exception of curatively treated carcinoma in situ of the cervix or breast and/or superficial bladder cancer and/or gastrointestinal mucosal carcinoma and/or localized prostate cancer within the last 5 years

• History of severe hypersensitivity reaction to monoclonal antibodies

• Prior exposure to any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or CAR-T cell therapy

• Need the palliative irradiation during the study except for bone metastasis

• Need the other anticancer therapy during the study

• Received any anticancer vaccine within 3 months before first dosing

• Received ASCT within 3 months before first dosing or received Allo-SCT

• Active infection or an unexplained fever before first dosing

• Received a systematic antibiotics within 1 week of signing informed consent

• Subjects with any active autoimmune disease or history of autoimmune disease

• Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily Prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of KL-A167

• Serious medical diseases, ex Suffering from heart failure (New York Heart Association standard III or IV), ischemic heart disease (such as myocardial infarction or angina), uncontrolled diabetes(fasting blood glucose≥10 mmol/L), uncontrolled high blood pressure(Systolic> 150 mmHg and / or diastolic> 100 mmHg), LVEF<50%

• QTc>450 msec(male) or 470 msec(female)

• Electrocardiogram is abnormal and the researcher consider that KL-A167 has an additional risk to the subject

• Known active HBV or HCV infection

• Known HIV infection

• Has history of interstitial lung disease or non-infectious pneumonitis. Subjects with prior drug-induced or radiation-induced pneumonitis who are asymptomatic are eligible

• Known active pulmonary tuberculosis or has history of tuberculosis infection and are not controlled after treatment

• Has history of AE greater than or equal to level 3 related with immune system during the Immunotherapy

• Received a live vaccine within 4 weeks of the first dose of KL-A167 or plan to receive live vaccine during study period

• Known neurological or psychiatric diseases

• Ongoing alcohol or drug abuse

• Pregnancy or breast feeding

• Participation in another clinical trial within the past 1 month

• According to the investigator, other conditions that affect efficacy or safety of the research