NCT03239756

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

July 28, 2017

Last Update Submit

August 21, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    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]

    single dose cohort：112 days, multiple dose cohort：140 days

  • Area under the plasma concentration-time curve from time zero to infinity [AUC0-inf]

    single dose cohort：112 days, multiple dose cohort：140 days

  • Maximum observed maximum plasma concentration [Cmax]

    single dose cohort：112 days, multiple dose cohort：140 days

  • Time to reach the maximum observed plasma concentration [Tmax]

    single dose cohort：112 days, multiple dose cohort：140 days

  • Terminal elimination half-life[T1/2]

    single dose cohort：112 days, multiple dose cohort：140 days

  • +5 more secondary outcomes

Study Arms (4)

60 mg single dose cohort

EXPERIMENTAL

patients would receive a 60 mg single dose of TK006.

Biological: TK006

120 mg single dose cohort

EXPERIMENTAL

patients would receive a 120 mg single dose of TK006.

Biological: TK006

180 mg single dose cohort

EXPERIMENTAL

patients would receive a 180 mg single dose of TK006.

Biological: TK006

120 mg Q4W cohort

EXPERIMENTAL

patients would receive 120 mg TK006 every 4 weeks, for a total of 3 doses.

Biological: TK006

Interventions

TK006BIOLOGICAL

Subcutaneous injection

Also known as: fully human monoclonal anti-RANKL antibody
120 mg Q4W cohort120 mg single dose cohort180 mg single dose cohort60 mg single dose cohort

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients provide written informed consent voluntarily；
  • \~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:
  • 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).

You may not qualify if:

  • 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.
  • 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:
  • \) 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.
  • \. 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first affiliated hospital with Nanjing University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jiang H Y

    Jiangsu T-Mab Biopharma Co.,Ltd

    STUDY DIRECTOR

Central Study Contacts

Yu M X

CONTACT

15021830072yumingxia@sh-qingfeng.net

Jiang H B

CONTACT

13062892252jianghaibiao@sh-qingfeng.net

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 4, 2017

Study Start

July 20, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

CN(1)