An open label, single arm, multicenter phase II study of AST-301 in patients with advanced or metastatic salivary gland tumor with HER2 overexpressio
- Conditions
- Neoplasms
- Registration Number
- KCT0007106
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 36
1)Patients diagnosed as progressive or metastatic salivary gland cancer with age of 19 years or older on the day of signing the informed consent form and eligible for this study after TRIUMPH2 genome profiling and next genome sequencing(NGS) by molecular steering committee.
?HER2 IHC is 3+.
?If HER2 IHC is 2+, FISH/SISH = 2.0.
?If HER2 IHC is 0 or 1+, the number of HER2 gene copy have to be confirmed more than 6 copies through NGS.
2)Patients with progressed disease after surgery or locoregional therapy and unable to receive any more surgery or locoregional therapy.
3)At least one measurable target lesion according to RECIST version 1.1. A lesion in an area subjected to prior locoregional therapy is not considered measurable unless there has been demonstrated progression after the therapy as defined by RECIST version 1.1.
4)Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
5)Adequate organ function as indicated by the following laboratory values.
* Test items and approved standards.
- Bone marrow
Absolute neutrophil count (ANC) = 1500/µL
Platelets = 100,000/µL
Hemoglobin = 9.0g/dL or = 5.6mmol/L
- Renal
Creatinine or = 1.5 × ULN
Creatinine clearance (replaceable with eGFR) = 60mL/min
- Liver
Total bilirubin = 1.5 × ULN or > 1.5 × ULN and Direct bilirubin = ULN
AST (SGOT) and ALT (SGPT) = 2.5 × ULN (If a patient with liver progression, = 5 × ULN)
- Blood coagulation
INR or PT, aPTT = 1.5 × ULN or, a patient with anti-blood coagulation treatment and PT or aPTT is within the intended therapeutic range under treatment with anti-blood coagulation drugs.
?All laboratory test results (acquired from center or each participating sites) have to be reviewed by principal investigator or a delegated and qualified person (Before registering subjects).
?Eligible after restored from abnormal Hemoglobin value.
?Calculated value will be utilized for CrCl and eGFR according to calculation methods of each participating sites, based on measured creatinine value.
6)Patients signing the informed consent form before registering this study and understating their own right for withdrawing consent without any disadvantages whenever they want.
1)Patients previously treated with HER-2 signaling targeted drugs.
2)Patients prohibited from rhGM-CSF administration. (e.g., hypersensitive reaction against the drug, etc.)
3)Patients with other cancer history within 3 years except completely resolved skin cancer (except malignant melanoma), cervical carcinoma in situ or thyroid cancer without lymph node metastasis.
4)With uncontrolled CNS or brain metastasis.
5) Currently being received or has received immune inhibitors within 4 weeks of the first study drug(s) administration. Except for the following drugs:
?Intranasal, inhaled, external or topical injection(e.g. intra-articular injection) steroids.
?Systemic treatment with corticosteroids either > 10 mg daily of prednisone or equivalent.
?Treatment of corticosteroid prescribed prophylactically for hypersensitivity reaction. (e.g., prophylactic treatment for CT scan or cytotoxic chemotherapy)
6)A history of activated primary immunodeficiency syndrome.
7)Patients with currently active or history of immunodeficiency syndrome or inflammatory disease (inflammatory bowel disease, systemic erythematosus lupus, sarcoidosis, Wegener's granulomatosis or etc. Except for any of the following:
?A patient with vitiligo or alopecia.
?Controlled hypothyroidism (provided it is managed with hormone replacement therapy) or psoriasis not requiring systemic treatment.
?Skin diseases not requiring systemic treatment.
?Without any active disease for 5 years and consulted with a doctor in charge of the disease. 8)Any active infections including active tuberculosis (based on medical assessment including medical history, physical examination, radiological finding, tuberculosis test according to local practice.), Hepatitis B (HBV surface antigen [HBsAg] positive), Hepatitis C (HCV RNA positive) and Human immunodeficiency virus (HIV1/2 antibody positive).
Patients with any condition of the following are not excluded.
?Patients With history of HBV infection or recovered. (With Hepatitis B core antibody [anti-HBc] and without HBsAg).
?Patients with hepatitis C virus (HCV) antibody positive and negative results of PCR for HCV RNA.
?Patients treated and maintained with HBV treatment and HBV DNA is not detected continuously. (Test results = 1 month before the screening are required.)
?HCV RNA is not detected continuously after completion of HCV treatment. (Test results within 1 month before the screening are required.)
9)Patients with any major surgical procedure (according to investigator’s discretion) or significant traumatic injury = 28 days before the first dose of study drug(s) or major surgical procedures can be required during study drug administration. (Note: Topical surgery is allowed for independent lesions for the purpose of palliative treatment.).
10)Currently being received or received any radiological treatment = 14 days of the first study drug(s) administration.
11)Patients with toxicities which have not recovered to baseline or stabilized as a result of prior anticancer therapy (CTCAE 5.0 Grade 2 =). (Except for alopecia and anorexia.)
12)Uncontrolled severe systemic diseases including but not limited to the following diseases:
Ongoing or active infectious diseases, symptomatic congestive heart failure (meeting New York Heart Association (NYHA) Classification III or IV), uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease (ILD), significant chronic gastroin
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Objective response rate;Disease control rate;Overall survival