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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

TK006

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

immunogenicity

Neutralization antibody of TK006 would be detected on the day 0 (before dosing), day 28 (before dosing) and day 84.

Full Information

NCT ID

NCT03487055

First Posted

March 13, 2018

Last Updated

March 27, 2018

Sponsor

Jiangsu T-Mab Biopharma Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03487055

Brief Title

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

Official Title

Safety Assessment of Repeated Administration of a Fully Human Monoclonal Antibody of RNAKL (TK006) in Patients With Breast Cancer-related Bone Metastases

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 2018 (Anticipated)

Primary Completion Date

May 2019 (Anticipated)

Study Completion Date

May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu T-Mab Biopharma Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

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 Pharmacodynamics in Patients With Breast Cancer-related Bone Metastases (NCT 03239756). It's an open labelled study, aimed at evaluating the safety of repeated administration of TK006 in patients with breast cancer-related bone metastases. The qualified subjects would be those completed the entire observation in either 60 mg, 120 mg or 180 mg single dose arm at the core study. Also, these patients should be well-tolerated with TK006 at the core study and are deemed to further benefit from this extension phase estimated by the researcher and sponsor. The subjects would receive 120 mg TK006 every 4-week over a period of 84 days. Only safety profile and immunogenicity assessment would be assessed in this extension stage, and no further study on pharmacokinetics and pharmacodynamics would be done.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment group

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

TK006

Other Intervention Name(s)

fully human monoclonal anti-RANKL antibody

Intervention Description

Subcutaneous injection in the upper arm

Primary Outcome Measure Information:

Title

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

Description

Time Frame

85 days

Secondary Outcome Measure Information:

Title

immunogenicity

Description

Neutralization antibody of TK006 would be detected on the day 0 (before dosing), day 28 (before dosing) and day 84.

Time Frame

85 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yu M X

Phone

15021830072

yumingxia@sh-qingfeng.net

First Name & Middle Initial & Last Name or Official Title & Degree

jiang H B

Phone

13062892252

jianghaibiao@sh-qingfeng.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

jiang H Y

Organizational Affiliation

Jiangsu T-Mab Biopharma Co.,Ltd

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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