Clinical trial · Interventional
Safety Assessment of Repeated Administration of TK006 in Patients With Breast Cancer-related Bone Metastases
Safety Assessment of Repeated Administration of a Fully Human Monoclonal Antibody of RNAKL (TK006) in Patients With Breast Cancer-related Bone Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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: Phase 1 Trial of a Fully Human Monoclonal Antibody of Receptor Activator for Nuclear Factor-κ B Ligand (RNAKL, TK006) Safety, Pharmacokinetics, and Pharmacodynamics in Patients With Breast Cancer-related Bone Metastases (NCT 03239756).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TK006 | Biological | Denosumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- The subjects would receive 120 mg TK006 every 4-week over a period of 84 days.
- interventionNames
- Biological: TK006
Primary outcomes (1)
- measure
- Incidence of adverse events（AEs）which are related to TK006 treatment throughout the study
- timeFrame
- 85 days
- description
- Adverse events refer to any treatment related abnormality with clinical significance identified by means of vital signs examination, physical check-up, twelve leads electrocardiogram inspection and laboratory tests throughout the study. Adverse events reported by subjects would also be recorded in the entire trial. All these abnormal cases described above would be reported as incidence of adverse events.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients provide written informed consent voluntarily. 2. 18\~65 years old, male or female. 3. 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. 4. ECOG≤2. 5. Albumin-adjusted calcium≥2.0mmol/L, ≤2.9mmol/ L. Exclusion Criteria: 1. Women in pregnancy or nursing. 2. Central nervous system metastasis that is symptomatic or require treatment. 3. Patients with grade III or IV adverse events considered related to TK006 at the core phase (NCT 03239756). 4. Patients with important organs dysfunction and not suitable for further treatment with TK006 judged by the researcher. 5. Imaging confirmed progression in bone metastasis compared with core phase (NCT 03239756). 6. 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. 7. Patients who have been selected for the study of other test devices or test medicine. 8. Other situations which are not suitable for participation judged by the researcher.
References
Publications (0)
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