Safety Assessment of Repeated Administration of TK006 in Patients With Breast Cancer-related Bone Metastases

NCT03487055 | Unknown Phase 1

• 1 other identifier: Tmab-TK006-102b
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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: 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events（AEs）which are related to TK006 treatment throughout the study

  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.

  85 days

Secondary Outcomes (1)

• immunogenicity

  85 days

Study Arms (1)

treatment group

EXPERIMENTAL

The subjects would receive 120 mg TK006 every 4-week over a period of 84 days.

Biological: TK006

Interventions

TK006 BIOLOGICAL

Subcutaneous injection in the upper arm

Also known as: fully human monoclonal anti-RANKL antibody

treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients provide written informed consent voluntarily.
• \~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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu T-Mab Biopharma Co.,Ltd: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• jiang H Y

  Jiangsu T-Mab Biopharma Co.,Ltd

  STUDY DIRECTOR

Central Study Contacts

Yu M X

CONTACT

15021830072; yumingxia@sh-qingfeng.net

jiang H B

CONTACT

13062892252; jianghaibiao@sh-qingfeng.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: April 3, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: April 3, 2018

Record last verified: 2018-03