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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05349643

Registration number

NCT05349643

Ethics application status

Date submitted

22/04/2022

Date registered

27/04/2022

Titles & IDs

Public title

A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT

Scientific title

A Phase 2, Open-Label, Adaptive, Dose-Ranging Study With Long-Term Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra Articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor

Secondary ID [1]

AMB-051-07

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pigmented Villonodular Synovitis

TGCT

Tenosynovial Giant Cell Tumor

Condition category

Condition code

Cancer

Bone

Cancer

Other cancer types

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Other - AMB-05X

Experimental: AMB-05X - Subjects will receive an injection of AMB-05X once every 4 weeks for 24 weeks (for 6 treatments total). Based on ongoing review of the available safety, PK, PD, and efficacy data, the Sponsor may either increase or decrease the dose.

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

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Objective Response Rate - Part 1

Timepoint [1]

Part 1 Week 24

Primary outcome [2]

Treatment-emergent adverse events

Timepoint [2]

Part 1 Week 24 and Part 2 Week 72

Secondary outcome [1]

Objective Response Rate

Timepoint [1]

Part 2 Week 72

Secondary outcome [2]

Objective Response Rate (AMB-051-01 subjects)

Timepoint [2]

Part 2 Week 72

Secondary outcome [3]

Objective Response Rate (ORR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1

Timepoint [3]

Part 1 Week 24

Secondary outcome [4]

Objective Response Rate (ORR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1

Timepoint [4]

Part 2 Week 72

Secondary outcome [5]

Tumor response based on tumor volume score (TVS)

Timepoint [5]

Part 1 Week 24

Secondary outcome [6]

Tumor response based on tumor volume score (TVS)

Timepoint [6]

Part 2 Week 72

Secondary outcome [7]

Duration of Response by Response Evaluation Criteria in Solid Tumors

Timepoint [7]

Part 1 Week 24

Secondary outcome [8]

Duration of Response by Response Evaluation Criteria in Solid Tumors v1.1

Timepoint [8]

Part 2 Week 72

Secondary outcome [9]

Duration of Response by Modified Response Evaluation Criteria in Solid Tumors

Timepoint [9]

Part 1 Week 24

Secondary outcome [10]

Duration of Response by Modified Response Evaluation Criteria in Solid Tumors

Timepoint [10]

Part 2 Week 72

Secondary outcome [11]

Duration of Response by tumor volume score

Timepoint [11]

Part 1 Week 24

Secondary outcome [12]

Duration of Response by tumor volume score

Timepoint [12]

Part 2 Week 72

Secondary outcome [13]

Time to Response by Response Evaluation Criteria in Solid Tumors

Timepoint [13]

Part 1 Week 24

Secondary outcome [14]

Time to Response by Response Evaluation Criteria in Solid Tumors

Timepoint [14]

Part 2 Week 72

Secondary outcome [15]

Time to Response by Modified Response Evaluation Criteria in Solid Tumors

Timepoint [15]

Part 1 week 24

Secondary outcome [16]

Time to Response by Modified Response Evaluation Criteria in Solid Tumors

Timepoint [16]

Part 2 Week 72

Secondary outcome [17]

Time to Response per tumor volume score

Timepoint [17]

Part 1 Week 24

Secondary outcome [18]

Time to Response per tumor volume score

Timepoint [18]

Part 2 Week 72

Secondary outcome [19]

Mean change from Baseline in joint range of motion (ROM)

Timepoint [19]

Part 1 Week 24

Secondary outcome [20]

Mean change from Baseline in joint range of motion (ROM)

Timepoint [20]

Part 2 Week 72

Secondary outcome [21]

Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score

Timepoint [21]

Part 1 Week 24

Secondary outcome [22]

Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score

Timepoint [22]

Part 2 Week 72

Secondary outcome [23]

Mean change from Baseline in Worst Stiffness Numeric Rating Scale score

Timepoint [23]

Part 1 Week 24

Secondary outcome [24]

Mean change from Baseline in Worst Stiffness Numeric Rating Scale score

Timepoint [24]

Part 2 Week 72

Secondary outcome [25]

Mean change from Baseline in the Brief Pain Inventory (BPI) score

Timepoint [25]

Part 1 Week 24

Secondary outcome [26]

Mean change from Baseline in the Brief Pain Inventory (BPI) score

Timepoint [26]

Part 2 Week 72

Secondary outcome [27]

Decrease of at least 30% in mean Brief Pain Inventory (BPI) from Baseline

Timepoint [27]

Part 1 Week 24

Secondary outcome [28]

Decrease of at least 30% in mean Brief Pain Inventory (BPI) from Baseline

Timepoint [28]

Part 2 Week 72

Secondary outcome [29]

Mean change from Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference score

Timepoint [29]

Part 1 Week 24

Secondary outcome [30]

Mean change from Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference score

Timepoint [30]

Part 2 Week 72

Secondary outcome [31]

Mean change from Baseline in Patient Global Impression of Change in Physical Functioning for capacity to perform everyday tasks

Timepoint [31]

Part 1 Week 24

Secondary outcome [32]

Mean change from Baseline in Patient Global Impression of Change in Physical Functioning for capacity to perform everyday tasks

Timepoint [32]

Part 2 Week 72

Secondary outcome [33]

Mean change from Baseline in Patient Global Impression of Change in tenosynovial giant cell tumor-related stiffness score

Timepoint [33]

Part 1 Week 24

Secondary outcome [34]

Mean change from Baseline in Patient Global Impression of Change in tenosynovial giant cell tumor-related stiffness score

Timepoint [34]

Part 2 Week 72

Secondary outcome [35]

Mean change from Baseline in Worst Pain Numeric Rating Scale score

Timepoint [35]

Part 1 Week 24

Secondary outcome [36]

Mean change from Baseline in Worst Pain Numeric Rating Scale score

Timepoint [36]

Part 2 Week 72

Secondary outcome [37]

EuroQol 5 Dimension 5 Level Health Assessment

Timepoint [37]

Part 1 Week 24

Secondary outcome [38]

EuroQol 5 Dimension 5 Level Health Assessment

Timepoint [38]

Part 2 Week 72

Eligibility

Key inclusion criteria

1. Subject = 18 years
2. TGCT with only 1 joint involvement
3. Symptomatic Measurable disease of at least 1 cm based on RECIST v1.1
4. Stable prescription of analgesic regimen
5. Agrees to follow contraception guidelines
6. Women of childbearing potential must have a negative pregnancy test
7. Adequate hematologic, hepatic, and renal function

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
2. Previous use of therapeutics targeting CSF1 or CSF1R or oral tyrosine kinase inhibitors within 3 months prior to Baseline
3. History of extensive or reconstructive surgery on the affected joint
4. Active cancer (either currently or within 3 mo before Baseline) that requires/required therapy (e.g., surgery, chemotherapy, or radiation therapy)
5. Metastatic or malignant transformation of TGCT
6. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
7. Known active tuberculosis
8. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history
9. Women who are breastfeeding
10. A screening Fridericia-corrected QT interval (QTcF) = 470 ms
11. MRI contraindications (e.g., pacemaker, loose metallic implants)
12. History of hypersensitivity to any ingredient of the study drug
13. History of drug or alcohol abuse within 3 months before baseline
14. 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 or interfere with interpretation of study results and, in the Investigator's opinion, make the subject inappropriate for this study
15. Subjects who, in the Investigator's opinion, should not participate in the study for any reason, including if there is a question about their ability to comply with study requirements

Study design

Purpose of the study

Treatment

Allocation to intervention

Not applicable

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Phase 2

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

26/01/2023

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

3/06/2024

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

AmMax Bio, Clinical Site - Camperdown

Recruitment hospital [2]

AmMax Bio, Clinical Site - Woolloongabba

Recruitment postcode(s) [1]

- Camperdown

Recruitment postcode(s) [2]

- Woolloongabba

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

California

Country [2]

United States of America

State/province [2]

Florida

Country [3]

United States of America

State/province [3]

Texas

Country [4]

Netherlands

State/province [4]

Leiden

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

AmMax Bio, Inc.

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension in adults with tenosynovial giant cell tumor

Trial website

https://clinicaltrials.gov/study/NCT05349643

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dorothy Nguyen, MD

Address

AmMax Bio

Country

Phone

Fax

Contact person for public queries

Name

Tiffany Nguyen

Address

Country

Phone

6502856560

Fax

clinical@ammaxbio.com

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05349643

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05349643