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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
EU CTIS ID: 2023-507328-22-00
What this study is testing
The objectives of this study are to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of intra-articular (IA) AMB-05X in the treatment of tenosynovial giant cell tumor (TGCT), both after an initial 24 weeks of treatment (Part 1) and after extended treatment and/or observation (Part 2).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has never received AMB-05X in another study.
- A subject may be enrolled directly into Part 2 of this study without completing Part 1 if ALL of the following criteria are met:
- Have measurable disease of at least 1 cm per RECIST v1.1, assessed from MRI scans by central radiology review, and received treatment in Study AMB-051-01.
- Able to understand and willing to adhere to the requirements of this study. Voluntarily signs the ICF before the conduct of any study-specific procedures.
- Agrees to follow contraception guidelines
- Adequate hematologic, hepatic, and renal function at Screening.
You likely can't join if
- Use of any investigational drug within 4 weeks or 5 half-lives (whichever is longer) before Study Baseline
- Current or prior radiotherapy within 3 months before Study Baseline.
- Current or prior active cancer within 3 years before Study Baseline that requires/required therapy (eg, surgery, chemotherapy, or radiation therapy), except adequately treated basal or squamous cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix or breast, or prostate carcinoma not requiring treatment apart from active surveillance.
- Known metastatic TGCT or malignant transformation of TGCT.
- Hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or chronic infection with human immunodeficiency virus (HIV).
- Known active tuberculosis (TB).
See the full eligibility criteria
Who can join
- Has never received AMB-05X in another study.
- A subject may be enrolled directly into Part 2 of this study without completing Part 1 if ALL of the following criteria are met:
- Have measurable disease of at least 1 cm per RECIST v1.1, assessed from MRI scans by central radiology review, and received treatment in Study AMB-051-01.
- Able to understand and willing to adhere to the requirements of this study. Voluntarily signs the ICF before the conduct of any study-specific procedures.
- Agrees to follow contraception guidelines
- Adequate hematologic, hepatic, and renal function at Screening.
- Symptomatic TGCT
- Male or female ≥ 18 years of age.
- Able to understand and willing to adhere to the requirements of this study. Voluntarily signs the informed consent form (ICF) before the conduct of any study-specific procedures.
- TGCT with only 1 joint involvement that has been diagnosed histologically by a pathologist and documented. If a histological diagnosis has not been made previously, biopsy with histological diagnosis is required before enrollment. a. Individuals with TGCT of the knee joint are eligible. Depending on results in Cohort A and the recommendations of the DMC, individuals with TGCT of the hip and shoulder joint may also be allowed after Cohort A. b. Individuals with TGCT that are amenable or non-amenable to surgery are eligible.
- Measurable disease of at least 1 cm per RECIST v1.1, assessed from MRI scans by central radiology review.
- If the subject uses prescription analgesic, the subject must be on a stable prescription analgesic regimen during the 2 weeks before Baseline.
- Agrees to follow contraception guidelines
- Adequate hematologic, hepatic, and renal function at Screening
- Symptomatic TGCT defined as at least 1 of the following: A BPI worst pain score of at least 4 before dosing at Baseline b. A Worst Stiffness NRS score of at least 4 before dosing at Baseline.
What rules you out
- Use of any investigational drug within 4 weeks or 5 half-lives (whichever is longer) before Study Baseline
- Current or prior radiotherapy within 3 months before Study Baseline.
- Current or prior active cancer within 3 years before Study Baseline that requires/required therapy (eg, surgery, chemotherapy, or radiation therapy), except adequately treated basal or squamous cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix or breast, or prostate carcinoma not requiring treatment apart from active surveillance.
- Known metastatic TGCT or malignant transformation of TGCT.
- Hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or chronic infection with human immunodeficiency virus (HIV).
- Known active tuberculosis (TB).
- Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the Investigator’s opinion, would likely interfere with the subject’s study participation or the interpretation of the subject’s results.
- An individual 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.
- An individual who, in the Investigator’s opinion, should not participate in this study for any reason, including instances where the subject’s stability or ability to comply with study requirements is in question.
- Subjects with TGCT that is only extra-articular by MRI.
- A female who is pregnant or breastfeeding. For females of childbearing potential, a positive pregnancy test at either Screening or Study Baseline will be exclusionary.
- A screening QT interval corrected using Fridericia’s formula (QTcF) ≥ 470 ms
- MRI contraindications (eg, pacemaker, loose metallic implants).
- History of hypersensitivity to any ingredient in the study drug.
- History of drug or alcohol abuse within 3 months before Study Baseline.
- 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.
- Use of any of the following: a. Pexidartinib, any other oral tyrosine kinase inhibitor (eg, imatinib or nilotinib), or any biologic treatment targeting CSF1 or CSF1R (except AMB-05X), within 3 months before the Baseline visit b. Current or recent (within 10 days before starting study treatment) full-dose oral anticoagulants (eg, warfarin), daily treatment with high-dose aspirin (>325 mg/day) or clopidogrel (>75 mg/day).
- History of extensive or reconstructive surgery on the affected joint (eg, involving plates, screws, or metal implants). A history of prior diagnostic or partial synovectomy is not exclusionary if performed at least 3 months before Study Baseline.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.