Active — Not RecruitingPhase 2

Study of INBRX-109 in Conventional Chondrosarcoma

United States206 participantsStarted 2021-09-23

Plain-language summary

Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed.
✕. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
✕. Other exclusion criteria per protocol.

Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo

Timeframe: 3 years

NCT IDNCT04950075

SponsorInhibrx Biosciences, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-30

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed.
✕. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
✕. Other exclusion criteria per protocol.