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A Phase 2 study of INBRX-109 in adults with a type of unresectable or metastasized cancer of the bones and joints (Conventional Chondrosarcoma)
EU CTIS ID: 2024-517528-20-00
What this study is testing
To evaluate the anticancer efficacy of INBRX-109 in the Intention To Treat (ITT) population as measured by Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECISTv1.1), assessed by central real-time indepedent radiology review (IRR), comparing INBRX-109 and placebo.
- 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
- Males or females aged ≥ 18 to ≤ 85 years
- Conventional (or primary) chondrosarcoma, unresectable (i.e., not amenable to tumor resection with curative intent) or metastatic. Availability of archival tissue or fresh cancer biopsy are mandatory.
- Measurable disease by RECISTv1.1. Note: Tumor lesions located in a previously irradiated (or other locally treated) area will be considered measurable, provided there has been clear imaging-based progression of the lesions since the time of treatment.
- Evidence of confirmed radiographic disease progression per RECISTv1.1 criteria within 6 months prior to start of study treatment.
- Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
- ECOG PS of 0 or 1 (Exception: Inclusion of non-frail, physically active patients with compromised mobility due to prior cancer surgery (eg, limb amputation, hemipelvectomy) should be discussed with the Medical Monitor or Study Director)
You likely can't join if
- Any prior exposure to DR5 agonists.
- Allergy or sensitivity to INBRX-109 or known allergies to Chinese hamster ovary (CHO) cell-produced antibodies, which in the opinion of the Investigator suggest an increased potential for an adverse hypersensitivity to INBRX-109.
- Non-conventional CSs, eg, clear-cell, mesenchymal, extra-skeletal myxoid, myxoid, and dedifferentiated CS.
- Prior or concurrent malignancies. Exception: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments.
- Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed.
- Any evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
See the full eligibility criteria
- Males or females aged ≥ 18 to ≤ 85 years
- Conventional (or primary) chondrosarcoma, unresectable (i.e., not amenable to tumor resection with curative intent) or metastatic. Availability of archival tissue or fresh cancer biopsy are mandatory.
- Measurable disease by RECISTv1.1. Note: Tumor lesions located in a previously irradiated (or other locally treated) area will be considered measurable, provided there has been clear imaging-based progression of the lesions since the time of treatment.
- Evidence of confirmed radiographic disease progression per RECISTv1.1 criteria within 6 months prior to start of study treatment.
- Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
- ECOG PS of 0 or 1 (Exception: Inclusion of non-frail, physically active patients with compromised mobility due to prior cancer surgery (eg, limb amputation, hemipelvectomy) should be discussed with the Medical Monitor or Study Director)
- Estimated life expectancy, in the documented judgment of the Investigator, of at least 12 weeks.
- Any prior exposure to DR5 agonists.
- Allergy or sensitivity to INBRX-109 or known allergies to Chinese hamster ovary (CHO) cell-produced antibodies, which in the opinion of the Investigator suggest an increased potential for an adverse hypersensitivity to INBRX-109.
- Non-conventional CSs, eg, clear-cell, mesenchymal, extra-skeletal myxoid, myxoid, and dedifferentiated CS.
- Prior or concurrent malignancies. Exception: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments.
- Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed.
- Any evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United Kingdom
- 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 Kingdom; 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.