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

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ClinicalTrials.gov Identifier: NCT03848286
Recruitment Status : Not yet recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Tracking Information
First Submitted Date  ICMJE February 12, 2019
First Posted Date  ICMJE February 20, 2019
Last Update Posted Date February 20, 2019
Estimated Study Start Date  ICMJE February 28, 2019
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
Objective Response Rate (ORR) assess by Independent Review Committee (IRC) [ Time Frame: from first patient first visit to 6 month after last patient first visit ]
Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
  • ORR assess by investigators [ Time Frame: from first patient first visit to 6 month after last patient first visit ]
    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and Immune-related Response Evaluation Criteria In Solid Tumors 1.1 (irRECIST 1.1)
  • Progression-Free Survival (PFS) [ Time Frame: up to approximately 1 year ]
    PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
  • Overall Survival (OS) [ Time Frame: up to approximately 1 year ]
    Overall Survival is defined as the time from registration to death due to any cause, or censored at date last known alive
  • Disease Control Rate (DCR) [ Time Frame: from first patient first visit to 6 month after last patient first visit ]
    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
  • Duration of Response (DOR) [ Time Frame: up to approximately 1 year ]
    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
  • Time to Response(TTR) [ Time Frame: from first patient first visit to 6 month after last patient first visit ]
    From the date of the first dose of KL-A167 to the time the response criteria are first met
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy
Official Title  ICMJE 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Nasopharyngeal Carcinoma
  • Recurrent or Metastatic
Intervention  ICMJE Drug: KL-A167 Injection
KL-A167 900 mg intravenously (IV) every-2-weeks (Q2W)
Study Arms  ICMJE Experimental: Experimental
KL-A167 900 mg intravenously (IV) every-2-weeks (Q2W)
Intervention: Drug: KL-A167 Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 19, 2019)
112
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2020
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dawei Wu 010-87788268 wumingshi-117@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03848286
Other Study ID Numbers  ICMJE KL167-Ⅱ-05-CTP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Study Sponsor  ICMJE Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP