A Phase 1 interventional study of TK006 in Breast Cancer, sponsored by Jiangsu T-Mab Biopharma Co.,Ltd. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-08-23.
Sponsored by Jiangsu T-Mab Biopharma Co.,Ltd · Phase 1, Interventional, and Treatment
This is a single-center, open-label, dose-escalating study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of single and multiple subcutaneous injection TK006 in patients with breast cancer-related bone metastases.
This is an single-center, open-label, dose-escalating study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of single and multiple subcutaneous injection TK006 in patients with breast cancer-related bone metastases. It contains 4 cohorts：60 mg single-dose conhort, 120 mg single-dose conhort, 180 mg single-dose conhort and 120 mg Q4W （one dose every 4 weeks, 3 dose totally） conhort.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Jiangsu T-Mab Biopharma Co.,Ltd is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate reservation of hematopoiesis, liver and kidney functions:
Exclusion Criteria:
patients would receive a 60 mg single dose of TK006.
Biological: TK006
patients would receive a 120 mg single dose of TK006.
Biological: TK006
patients would receive a 180 mg single dose of TK006.
Biological: TK006
patients would receive 120 mg TK006 every 4 weeks, for a total of 3 doses.
Biological: TK006
Subcutaneous injection
Also known as: fully human monoclonal anti-RANKL antibody
Frequency of adverse events (AEs) and serious adverse events (SAEs) which are related to TK006 assessed by CTCAE v4.03
Collect the information of AEs and SAEs, vital sign, physical examination, laboratory examination and electrocardiogram during the trial.
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
Area under the plasma concentration-time curve from time zero to time 'last' where last is the last time point after administration [AUClast]
Calculated by the linear trapezoidal method.
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
Area under the plasma concentration-time curve from time zero to infinity [AUC0-inf]
Calculated by the linear trapezoidal and extrapolation method.
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
Maximum observed maximum plasma concentration [Cmax]
The maximum (or peak) serum concentration that TK006 achieves after the drug has been administrated and before the administration of a second dose.
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
Time to reach the maximum observed plasma concentration [Tmax]
The time at which the Cmax is observed.
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
Terminal elimination half-life[T1/2]
The time required to divide the plasma concentration by two after reaching pseudo-equilibrium, and not the time required to eliminate half the administered dose.
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
bioavailability corrected apparent volume of the central compartment cleared of drug per unit [Cl/F]
The apparent volume of the central compartment cleared of drug per unit time was estimated using the formula: Cl/F = Dose / AUC0-∞
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
bioavailability corrected apparent volume of distribution [Vd/F]
Apparent volume of distribution based on the terminal elimination phase.
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
urine creatinine corrected cross-linked N-telopeptides of type I collagen [uNTX/Cr]
For singel dose cohort, detecting the level of uNTX at screening period, day 0 (before dosing)、day 1, day 7, day 14, day 28, day 56, day 84 and day 112 For multiple dose cohort：detecting the level of uNTX at screening period, day 0 (before dosing)、day 1, day 7, day 14, day 28 (before dosing), day 56 (before dosing), day 84 and day 140. Assessing the change of uNTX level to baseline and the uNTX should be corrected by urine creatinine.
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
serum bone alkaline phosphatase [bALP]
Assessing the change of serum bALP level to baseline. For singel dose cohort, detecting the level of uNTX at screening period, day 0 (before dosing)、day 1, day 7, day 14, day 28, day 56, day 84 and day 112 For multiple dose cohort：detecting the level of uNTX at screening period, day 0 (before dosing)、day 1, day 7, day 14, day 28 (before dosing), day 56 (before dosing), day 84 and day 140.
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
anti-drug antibody [ADA]
Quantitative assay the ADA. For single cohort, the ADA titer would be detected at day 0 (before dosing) and day 56. For multiple dose cohort, the ADA titer would be detected at day 0 (before dosing), day 28 (before dosing), day 56 (before dosing), day 84 and day 140.
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Jiangsu T-Mab Biopharma Co.,Ltd