Status:
UNKNOWN
Safety Assessment of Repeated Administration of TK006 in Patients With Breast Cancer-related Bone Metastases
Lead Sponsor:
Jiangsu T-Mab Biopharma Co.,Ltd
Conditions:
Breast Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is an open labelled study. It was designed to evaluate the safety of multiple-dosing of TK006 in patients with breast cancer-related bone metastases. This trial is the extension of a core study: ...
Detailed Description
This trial is the extension of a core study: Phase 1 Trial of a Fully Human Monoclonal Antibody of Receptor Activator for Nuclear Factor-κ B Ligand (RNAKL, TK006) Safety, Pharmacokinetics, and Pharmac...
Eligibility Criteria
Inclusion
- Patients provide written informed consent voluntarily.
- 18\~65 years old, male or female.
- Patients who completed the entire observation in either 60 mg, 120 mg or 180 mg single dose arm at the core phase (NCT 03239756). Also, these patients should be well-tolerated with TK006 and would further benefit from continued treatment estimated by the researcher and sponsor.
- ECOG≤2.
- Albumin-adjusted calcium≥2.0mmol/L, ≤2.9mmol/ L.
Exclusion
- Women in pregnancy or nursing.
- Central nervous system metastasis that is symptomatic or require treatment.
- Patients with grade III or IV adverse events considered related to TK006 at the core phase (NCT 03239756).
- Patients with important organs dysfunction and not suitable for further treatment with TK006 judged by the researcher.
- Imaging confirmed progression in bone metastasis compared with core phase (NCT 03239756).
- Previous or existing osteomyelitis or osteonecrosis of jaw, toothache or jaw diseases which are in active or require invasive operations, unhealed wound of oral surgery, or planned invasive dental operations during this trial.
- Patients who have been selected for the study of other test devices or test medicine.
- Other situations which are not suitable for participation judged by the researcher.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03487055
Start Date
May 1 2018
End Date
May 1 2019
Last Update
April 3 2018
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