Assessment of TK006 in Patients With Breast Cancer-related Bone Metastases
NCT ID: NCT03239756
Last Updated: 2017-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2017-07-20
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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60 mg single dose cohort
patients would receive a 60 mg single dose of TK006.
TK006
Subcutaneous injection
120 mg single dose cohort
patients would receive a 120 mg single dose of TK006.
TK006
Subcutaneous injection
180 mg single dose cohort
patients would receive a 180 mg single dose of TK006.
TK006
Subcutaneous injection
120 mg Q4W cohort
patients would receive 120 mg TK006 every 4 weeks, for a total of 3 doses.
TK006
Subcutaneous injection
Interventions
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TK006
Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 18\~65 years old；
3. Patients with pathology confirmed breast cancer radiological evidence with bone metastasis；
4. Eastern Cooperative Oncology Group(ECOG) performance status≤2
5. Anticipated life span≥6-month；
6. Adequate reservation of hematopoiesis, liver and kidney functions:
* Absolute neutrophil count (ANC) ≥1.5×10\^9/L
* Absolute platelet count (PLT) ≥100×10\^9/L
* Hemoglobin (Hb) ≥90 g/L
* Total bilirubin (TBIL) ≤1.0 time the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0 ULN
* Serum creatinine (sCr) ≤2.0 ULN
7. Albumin-adjusted calcium≥2.0 mmol/L, ≤2.9 mmol/ L(Calcium supplements are not allowed within 8 hours before examination).
Exclusion Criteria
2. Women in Pregnancy or nursing.
3. Anti-human immunodeficiency virus (HIV) antibody positive.
4. Patients with hepatitis B virus DNA ≥10\^5 copies/mL or active hepatitis C would not be selected. Stable hepatitis B or hepatitis C defined as AST/ALT≤2 ULN will not be selected as well if patients are not treated with antiviral therapy while receving immunosuppressive therapy or chemotherapy meanwhile.
5. Prior malignancies (excluding the targeted breast cancer, basal cell carcinoma, or cervical cancer in situ) within 3 years.
6. Uncontrolled systemic diseases, or organic or mental disorders that could affect compliance.
7. Central nervous system metastasis that is symptomatic or require treatment.
8. Unresolved toxicities ≥2 grades from previous chemo-therapy (excluding alopecia).
9. Major surgery of bone or trauma within 4 weeks before the first dosing.
10. Fracture of long bone within 90-day before the first dosing.
11. Radiation therapy to bone within 2 weeks or treatment with radioisotopes within 8 weeks before the first dosing.
12. Treatment with diphosphonate within 30-day or administration of calcitonin, parathyroid hormone-related peptides, mithramycin, gallium nitrate or strontium ranelate within 6-month before the first dosing. Plan to receive systemic treatment with glucocorticosteroids over a long period during the trial.
13. Hyperthyroidism or hypothyroidism, unless hypothyroidism patients are receiving regular treatment with thyroid hormone and:
1\) Thyroid stimulating hormone (TSH) is normal, or 2) TSH\>4.78μIU/Ml, ≤10.0μIU/mL and thyroxine (T4) is normal. 14. Disorders of hypoparathyroidism or hyperparathyroidism, osteomalacia, rheumatoid arthritis, acute attack of osteoarthritis, gout, Paget's disease, malabsorption syndrome, ascites, or other diseases that could affect bone metabolism.
15\. Previous or existing osteomyelitis or osteonecrosis of jaw, odontia or jaw diseases which are in active or require invasive operations, unhealing wound of oral surgery, or planned invasive dental operations during this trial.
16\. Has been selected for the study of other test devices or test drugs, or the duration of the clinical studies that have taken less than 30 days or 5 half-lives or biological effects, whichever is longer.
17\. Other situations which are not suitable for participation judged by the principal investigator (PI).
18 Years
65 Years
ALL
No
Sponsors
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Jiangsu T-Mab Biopharma Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Jiang H Y
Role: STUDY_DIRECTOR
Jiangsu T-Mab Biopharma Co.,Ltd
Locations
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the first affiliated hospital with Nanjing University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Tmab-TK006-102
Identifier Type: -
Identifier Source: org_study_id
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