Clinical trial · Interventional
A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients
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
NCT04938180CI-TRIAL-00077470terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Further enrollment was halted in November 2021, enrolled subjects completed the study. Sponsor stopped further recruitment in this intravenous study to focus on intra-articular route of administration in subjects with tenosynovial giant cell tumor.
Summary
Brief summary (as posted)
The purpose of this Phase 2, open-label, multiple-dose, dose-escalation study is to evaluate intravenous AMB-05X in the treatment of subjects with TGCT.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pigmented Villonodular Synovitis | Tenosynovial Giant Cell Tumor, Diffuse Type | ALIAS | 0.90 |
| PVNS - Pigmented Villonodular Synovitis | — | UNRESOLVED | — |
| Tenosynovial Giant Cell Tumor | Tenosynovial Giant Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| TGCT | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMB-05X | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Each subject will receive a low dose of AMB-05X every 2 weeks, for a total of 6 doses over the 12-week treatment period.
- interventionNames
- Biological: AMB-05X
Primary outcomes (1)
- measure
- Treatment-emergent Adverse Events (TEAEs)
- timeFrame
- 6 months
- description
- The frequency and severity of reported TEAEs in Subjects with Tenosynovial Giant Cell Tumor (TGCT) receiving Intravenous AMB 05X.
Secondary outcomes (14)
- measure
- Overall Tumor Response (Objective Response) Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.