Breast CancerPhase 1NCT03239756
Assessment of TK006 in Patients With Breast Cancer-related Bone Metastases
A Phase 1 study testing TK006 in people with Breast Cancer, run by Jiangsu T-Mab Biopharma Co.,Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TK006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2017to Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients provide written informed consent voluntarily；
- 18~65 years old；
- Patients with pathology confirmed breast cancer radiological evidence with bone metastasis；
- Eastern Cooperative Oncology Group(ECOG) performance status≤2
- Anticipated life span≥6-month；
- Adequate reservation of hematopoiesis, liver and kidney functions:
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- 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
- Albumin-adjusted calcium≥2.0 mmol/L, ≤2.9 mmol/ L(Calcium supplements are not allowed within 8 hours before examination).
Who cannot join
- Hypersensitivity to any investigational medicine or supplements in this study.
- Women in Pregnancy or nursing.
- Anti-human immunodeficiency virus (HIV) antibody positive.
- 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.
- Prior malignancies (excluding the targeted breast cancer, basal cell carcinoma, or cervical cancer in situ) within 3 years.
- Uncontrolled systemic diseases, or organic or mental disorders that could affect compliance.
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- Central nervous system metastasis that is symptomatic or require treatment.
- Unresolved toxicities ≥2 grades from previous chemo-therapy (excluding alopecia).
- Major surgery of bone or trauma within 4 weeks before the first dosing.
- Fracture of long bone within 90-day before the first dosing.
- Radiation therapy to bone within 2 weeks or treatment with radioisotopes within 8 weeks before the first dosing.
- 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.
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first affiliated hospital with Nanjing University
Nanjing, Jiangsu, 210029
Yin Y M, 13951842727, ym.yin@hotmail.com
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- TK006
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TK006Biological
Also called fully human monoclonal anti-RANKL antibody
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 60 mg single dose cohort | Experimental | patients would receive a 60 mg single dose of TK006. Receives: Biological: TK006 |
| 120 mg single dose cohort | Experimental | patients would receive a 120 mg single dose of TK006. Receives: Biological: TK006 |
| 180 mg single dose cohort | Experimental | patients would receive a 180 mg single dose of TK006. Receives: Biological: TK006 |
| 120 mg Q4W cohort | Experimental | patients would receive 120 mg TK006 every 4 weeks, for a total of 3 doses. Receives: Biological: TK006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: single dose cohort：112 days, multiple dose cohort：140 days
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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-∞
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: single dose cohort：112 days, multiple dose cohort：140 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start20 Jul 2017
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu T-Mab Biopharma Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiang H Y, Study director, Jiangsu T-Mab Biopharma Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239756
- Sponsor's protocol ID
- Tmab-TK006-102
- Status last verified
- Aug 2017
- First submitted
- 28 Jul 2017
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03239756
- Acronym / sponsor ID
- Tmab-TK006-102
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jiangsu T-Mab Biopharma Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 4 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 60 mg single dose cohort | Experimental | Biological: TK006patients would receive a 60 mg single dose of TK006. |
| 120 mg single dose cohort | Experimental | Biological: TK006patients would receive a 120 mg single dose of TK006. |
| 180 mg single dose cohort | Experimental | Biological: TK006patients would receive a 180 mg single dose of TK006. |
| 120 mg Q4W cohort | Experimental | Biological: TK006patients would receive 120 mg TK006 every 4 weeks, for a total of 3 doses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients provide written informed consent voluntarily；
- 18~65 years old；
- Patients with pathology confirmed breast cancer radiological evidence with bone metastasis；
- Eastern Cooperative Oncology Group(ECOG) performance status≤2
- Anticipated life span≥6-month；
Key exclusion criteria (17 listed)
- Hypersensitivity to any investigational medicine or supplements in this study.
- Women in Pregnancy or nursing.
- Anti-human immunodeficiency virus (HIV) antibody positive.
- 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.
- Prior malignancies (excluding the targeted breast cancer, basal cell carcinoma, or cervical cancer in situ) within 3 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TK006Also: fully human monoclonal anti-RANKL antibodySubcutaneous injection | Biological | 120 mg Q4W cohort, 120 mg single dose cohort, 180 mg single dose cohort, 60 mg single dose cohort |
Primary outcome
Frequency of adverse events (AEs) and serious adverse events (SAEs) which are related to TK006 assessed by CTCAE v4.03
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
Collect the information of AEs and SAEs, vital sign, physical examination, laboratory examination and electrocardiogram during the trial.
10 secondary outcomes
Area under the plasma concentration-time curve from time zero to time 'last' where last is the last time point after administration [AUClast]
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]
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
Maximum observed maximum plasma concentration [Cmax]
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
Time to reach the maximum observed plasma concentration [Tmax]
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
Terminal elimination half-life[T1/2]
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]
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
bioavailability corrected apparent volume of distribution [Vd/F]
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]
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
serum bone alkaline phosphatase [bALP]
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
anti-drug antibody [ADA]
Time frame: single dose cohort：112 days, multiple dose cohort：140 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang H Y study director
Jiangsu T-Mab Biopharma Co.,Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TK006 in people with Breast Cancer, run by Jiangsu T-Mab Biopharma Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu M X (15021830072, yumingxia@sh-qingfeng.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events (AEs) and serious adverse events (SAEs) which are related to TK006 assessed by CTCAE v4.03 (time frame: single dose cohort：112 days, multiple dose cohort：140 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.