Clinical Trials

Inclusion Criteria:

• Males or females aged ≥ 18 years.
• Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.
• 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.
• Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.
• Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
• Estimated life expectancy of at least 12 weeks.
• Availability of archival tissue or fresh cancer biopsy are mandatory.

Exclusion Criteria:

• Any prior exposure to DR5 agonists.
• Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
• Non-conventional chondrosarcoma; e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
• 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 including but not limited to non-alcoholic steatohepatitis (NASH), alcohol-related liver disease, cirrhosis, hemochromatosis, Wilson’s disease, Alpha-1 antitrypsin deficiency, hepatic or biliary autoimmune disorders (e.g., primary biliary cholangitis, autoimmune hepatitis).
  • Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion criteria is confirmed.
• Acute viral (e.g., Hepatitis A virus, EBV etc.) or toxic liver disease within 4 weeks prior to the first dose of study treatment.
• Any evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
• Has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years.
  • Exception: Participants who have had a stem cell or bone marrow transplant > 5 years ago are eligible for enrollment, as long as there are no symptoms of graft-versus-host disease (GVHD).
• Major surgery within 4 weeks prior to this study.
• Systemic infection requiring antibiotics within 2 weeks prior to this study.
  • Exception: Local bacterial (UTI etc.), local viral or local fungal infections are permitted.
• Pregnant or nursing females during the duration of the study.
• Any known, documented, or suspected history of illicit substance abuse that would preclude patient from participation, unless clinically justified (i.e., will not interfere with study participation and/or will not compromise trial objectives) per judgment of the Investigator and with approval of the Medical Monitor or Study Director.
  • Exception: Physician-prescribed medicinal opioids or cannabinoids are allowed for pain management. Cannabinoids are allowed in patients from states that have legalized its use.
• Any other disease or clinically significant abnormality in laboratory parameters, including serious medical or psychiatric illness/condition likely in the judgment of the investigator.