Brief Title
KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy
Official Title
An Open, Multicenter Phase II Study to Evaluate the Safety and Efficacy of KL-A167 Injection in Recurrent/Metastatic Nasopharyngeal Carcinoma
Brief 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
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective Response Rate (ORR) assess by Independent Review Committee (IRC)
Secondary Outcome
ORR assess by investigators
Condition
Nasopharyngeal Carcinoma
Intervention
KL-A167 Injection
Study Arms / Comparison Groups
Experimental
Description: KL-A167 900 mg intravenously (IV) every-2-weeks (Q2W)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
112
Start Date
February 28, 2019
Completion Date
August 31, 2020
Primary Completion Date
August 31, 2020
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 010-87788268, [email protected]
Administrative Informations
NCT ID
NCT03848286
Organization ID
KL167-Ⅱ-05-CTP
Responsible Party
Sponsor
Study Sponsor
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Study Sponsor
, ,
Verification Date
February 2019