Study of INBRX-109 in Conventional Chondrosarcoma

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inhibrx, Inc.

Criteria

Inclusion Criteria:

1. Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.

2. 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.

3. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.

4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.

5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.

6. Estimated life expectancy of at least 12 weeks.

7. Availability of archival tissue or fresh cancer biopsy are mandatory.

Exclusion Criteria:

1. Any prior exposure to DR5 agonists.

2. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.

3. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.

4. 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.

5. Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion criteria is confirmed.

6. Other exclusion criteria per protocol.