HER-2 Protein Overexpression Clinical Trial
— BIOs-HerOfficial title:
Prospective Phase II Study to Investigate the Efficacy and Safety of Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Solid Tumor
Verified date | December 2019 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
HER2 signaling pathway abnormalities or HER2 overexpression can be seen in various types of
solid tumors apart from breast cancer or hepatic cancer. In this regardHER2 targeting therapy
has been proven to be effective in colorectal cancer, gallbladder cancer, and salivary gland
tumors. Although HER2 targeted-treatment Trastuzumab biosimilar is clinically being used
after gaining official permission recently, clinical data for this use is still lacking,
especially regarding experiences of combination with various cytotoxic chemotherapy agents.
Notably, techniques to separate and extract a small sized ciculating tumor DNA (ctDNA) in
patient's blood originated from a tumor is being developed and improved along with
introduction of Next-generation sequencing (NGS) technique enabling a comprehensive genetic
testing.
The aim of this study is to evaluate the efficacy and safety of Trastuzumab biosimiler and to
investigate the association between ctDNA and clinical outcomes such as disease response,
progression-free survival, and overall survival.
Status | Not yet recruiting |
Enrollment | 42 |
Est. completion date | December 30, 2019 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 79 Years |
Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed HER2 -overexpression (HER2 overexpression defined as 3+ positive by immunohistochemistry, positive by fluorescence in situ hybridization (FISH), or confirmation of HER2 amplification). However hepatic cancer and breast cancer are exclude as HER2 targeted treatment is already a standard treatment for these tumor types. - Patients who have progressed after at least one standard treatment or unable to continue standard treatment due to adverse events. - Patients confirmed as metastatic or unresectable cancer by imaging test - At least one measurable lesion that can be accurately assessed by imaging according to RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial entry - Adequate organ function (bone marrow, liver, kidney function) A. ANC = 1000/mL B.Platelets = 75,000/uL C.Hemoglobin >8.0 g/dL D.Total bilirubin = 2.0x ULN E.AST and ALT < 5.0 x ULN F.Alkaline phosphatase <2.5x ULN GCreatinine = 2.0x ULN or CCr >30 ml/min - Estimated life expectancy of more than 3 months - Left ventricular ejection fraction of at least = 50% at trial entry - Age =19 years who have signed an informed consent approved by Institutional Review Board of Organization Exclusion Criteria: - Either woman of pregnancy or breast-feeding woman who is positive for hCG - Symptomatic or unstable metastases to central nervous system (exceptions : properly treated brain metastasis with no evidence of progression on CT or MRI scan compared with prior examination and without requirement for steroid therapy for relief of symptom. Treatment of an anticonvulsant of stable dose for more than 4 months is permitted taken. - Evidence of viral, bacterial, or fungal infection including active hepatitis C and D or HIV infection. - Underwent major surgery of have not fully recovered from certain procedures within 4 months prior to taking the investigational product - History of malignant disease within 3 years prior to taking the investigational product (exceptions: treated carcinoma in situ of cervix, differentiated thyroid cancer without lymph node metastasis, and skin cancer other than melanoma). - Interval of QTc > 480 msec (in terms of average measurement of EKG 3 times), oneself or family known to be long or short QT, brugada syndrome or other known QTc prolongation history or Torsade de Pointes. - Following symptoms or disease within 6 months prior to taking the investigational product: myocardiac infarction, NCI CTCAE v 5.0 Grade =2 severe/unstable angina, continuous arrhythmia, atrial fibrillation, bypass surgery of coronary or peripheral arteries, symptomatic heart failure, cerebrovascular events including transient ischemic attack, or symptomatic pulmonary embolism. - History of symptomatic interstitial lung disease - Hypersensitivity reaction to Trastuzumab, Gemcitabine, Irinotecan or components of these agents - Patients with diarrhea, intestinal paralysis, intestinal obstruction, massive ascites, or pleural effusion - Other psychiatric problems, suicidal attempt, abnormal test results that can affect the administration of the investigational product or participation of clinical trial or that can impact the results of the clinical trial, and any other reason that investigator acknowledge as unsuitable factor for participating the clinical trial. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Jin-Hee Ahn | Asan Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | objective response rate | Best response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | 8 weeks | |
Secondary | Progression-free survival (PFS) | PFS is defined as the time from the first dose of trial treatment to the date of disease progression or death due to any cause, whichever occurs first. | 3 years | |
Secondary | overall survival (OS) | OS is defined as the time from the first dose of trial treatment to the death of all causes or the last follow-up. | 3 years | |
Secondary | Safety profile: NCI-CTCAE | Adverse events graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 | 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06055153 -
DV Combined With PD-1 and Platinum-based First-line Treatment in Patients With HER2 IHC2+/3+ ESCC
|
Phase 1/Phase 2 | |
Recruiting |
NCT05511844 -
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
|
Phase 1 | |
Terminated |
NCT02840110 -
Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product
|
||
Recruiting |
NCT04692831 -
Testing a New Imaging Agent to Identify Cancer
|
Phase 1 | |
Withdrawn |
NCT04464967 -
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers
|
Phase 1/Phase 2 | |
Terminated |
NCT03680560 -
Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers
|
Phase 1 | |
Completed |
NCT03613168 -
Trastuzumab in HER2-positive Biliary Tract Cancer
|
Phase 2 | |
Withdrawn |
NCT04602117 -
ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT05480384 -
Adjuvant Trastuzumab Deruxtecan (Enhertu) & Nivolumab For Patients Who Are Disease Free After Completion of Trimodality Treatment For HER-2+ Cancers of Esophagus & Gastroesophageal Junction
|
Phase 2 | |
Enrolling by invitation |
NCT05904730 -
Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations
|
Phase 1 | |
Not yet recruiting |
NCT06187506 -
Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer
|
Phase 2 | |
Terminated |
NCT03630809 -
Immune Response and Potential Booster for Patients Who Have Received HER2-pulsed DC1
|
Phase 2 | |
Recruiting |
NCT05170256 -
Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma Patients
|
Phase 2 | |
Active, not recruiting |
NCT04660929 -
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04995003 -
HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma
|
Phase 1 | |
Suspended |
NCT04650451 -
Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05868226 -
PRE-I-SPY Phase I/Ib Oncology Platform Program
|
Phase 1 | |
Not yet recruiting |
NCT04179656 -
The Basket Study of Pyrotinib Maleate for HER2-Postive Solid Tumor
|
Phase 2 |