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

NCT ID: NCT03487055

Last Updated: 2018-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2019-05-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment group

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

Group Type: EXPERIMENTAL

TK006

Intervention Type: BIOLOGICAL

Subcutaneous injection in the upper arm

Interventions

TK006

Subcutaneous injection in the upper arm

Intervention Type: BIOLOGICAL

Other Intervention Names

fully human monoclonal anti-RANKL antibody

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu T-Mab Biopharma Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

jiang H Y

Role: STUDY_DIRECTOR

Jiangsu T-Mab Biopharma Co.,Ltd

Central Contacts

Yu M X

Role: CONTACT

yumingxia@sh-qingfeng.net

15021830072

jiang H B

Role: CONTACT

jianghaibiao@sh-qingfeng.net

13062892252

Other Identifiers

Tmab-TK006-102b

Identifier Type: -

Identifier Source: org_study_id