A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients

Tenosynovial Giant Cell Tumor Clinical Trial

Official title:

A Phase 2, Adaptive, Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Intravenous AMB-05X in Subjects With Tenosynovial Giant Cell Tumor

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04938180
• Other study ID #: AMB-051-02
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 16, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: July 2022
• Source: AmMax Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this Phase 2, open-label, multiple-dose, dose-escalation study is to evaluate intravenous AMB-05X in the treatment of patients with TGCT.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: October 31, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject = 18 years

2. A confirmed diagnosis of TGCT

3. Measurable disease based on RECIST v1.1

4. Symptomatic disease

5. Stable prescription of analgesic regimen

6. Agrees to follow contraception guidelines

7. Adequate hematologic, hepatic, and renal function, at Screening

8. Willing and able to complete self-assessment instruments throughout the study

Exclusion Criteria:

1. Prior investigational drug use within 4 weeks or 5 half-lives of Baseline

2. Current or prior radiotherapy within 3 months before Baseline

3. Current or prior active cancer within 3 years before Baseline that requires/required therapy (eg, surgery, chemotherapy, or radiation therapy)

4. Known metastatic TGCT or malignant transformation of diffuse-type TGCT

5. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or chronic infection with human immuno deficiency virus (HIV)

6. Known active tuberculosis (TB)

7. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history

8. Women who are pregnant or breastfeeding

9. Screening Fridericia-corrected QT interval(QTcF) =450ms (men) or =470ms (women)

10. MRI contraindications (eg, pacemaker, loose metallic implants)

11. History of hypersensitivity to any ingredient in the study drug

12. History of drug or alcohol abuse within 3 months before Baseline

13. Has any other severe acute or chronic medical or psychiatric condition or clinically significant laboratory abnormality that may increase the risk associated with study participation/treatment, interfere with interpretation of study results, or, in the Investigator's opinion, make the subject inappropriate for this study

14. A person who is held in detention as the result of a judicial or official decision or who is in a subordinate relationship to the Sponsor or Investigator

15. A subject who, in the opinion of the Investigator, should not participate in the study for any reason, including if there is a question about the subject's ability to comply with study requirements

Related Conditions & MeSH terms

• Giant Cell Tumor of Tendon Sheath
• Giant Cell Tumors
• Pigmented Villonodular Synovitis
• Synovitis
• Synovitis, Pigmented Villonodular
• Tenosynovial Giant Cell Tumor

Intervention

Biological:
• AMB-05X
A fully human monoclonal immunoglobulin (IgG2) directed against c-fms

Locations

Country	Name	City	State
Germany	AmMax Bio Clinical Site	Berlin
Poland	AmMax Bio Clinical Site	Warsaw
Ukraine	AmMax Bio Clinical Site	Dnipro
Ukraine	AmMax Bio Clinical Site	Kharkiv
Ukraine	AmMax Bio Clinical Site	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
AmMax Bio, Inc.

Countries where clinical trial is conducted

Germany,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall tumor response per RECIST	Proportion of subjects achieving overall tumor response per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	Week 12
Secondary	Treatment-emergent adverse events	Frequency and severity of reported treatment-emergent adverse events	Up to week 24
Secondary	Tumor response based on tumor volume	Proportion of subjects with overall response based on tumor volume score	Week 12
Secondary	Mean change from baseline in range of motion (ROM)	ROM of the joint will be assessed by qualified assessors. Measurements will be recorded in degrees. At baseline, the plane of movement with the smallest (worst) relative value will be identified; only this plane will be used for evaluating the change in ROM subsequently.	Week 12
Secondary	Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score	The PROMIS Physical Function Scale will be used to assess physical function. The scale ranges from 1 ('unable to do' or 'cannot do') to 5 ('without any difficulty' or 'not at all'), where higher scores represent better outcomes.	Week 12
Secondary	Mean change from Baseline in Worst Stiffness Numeric Rating Scale (NRS) score	The Worst Stiffness NRS is a 1-item, self-administered questionnaire assessing the "worst" stiffness within the last 24 hours. The NRS for this item ranges from 0 (no stiffness) to 10 (stiffness as bad as you can imagine).	Week 12
Secondary	Mean change from Baseline in Worst Pain NRS score	The Worst Pain NRS is a component of the Brief Pain Inventory assessing the "worst" pain in the last 24 hours. The NRS for this item ranges from 0 (no pain) to 10 (pain as bad as you can imagine).	Week 12
Secondary	Mean change from Baseline in the Brief Pain Inventory (BPI) score	Brief Pain Inventory (BPI) Short Form is a self-administered questionnaire used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. The subject is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a scale from 0 to 10.	Week 12
Secondary	EQ-5D-5L (EuroQol-5 Dimension-5 Level) Health Assessment	EQ-5D-5L (EuroQol-5 Dimension-5 Level) is a widely used quality of life instrument that includes questions in each of 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The choices include 5 levels of severity for each domain followed by a general health visual analogue scale (VAS).	Week 12