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

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

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).

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Biological: TK006

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; The subjects would receive 120 mg TK006 every 4-week over a period of 84 days.	Biological: TK006; Subcutaneous injection in the upper arm; Other Names: fully human monoclonal anti-RANKL antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
immunogenicity	Neutralization antibody of TK006 would be detected on the day 0 (before dosing), day 28 (before dosing) and day 84.	85 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: March 27, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Tmab-TK006-102b

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No