Treatment of advanced chondrosarcoma with INBRX-109

A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma

Phase 2 Interventional Inhibrx Biosciences, Inc · NCT04950075

This study is testing a new treatment called INBRX-109 to see if it can help people with advanced chondrosarcoma that can't be surgically removed or has spread to other parts of the body.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment201 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorInhibrx Biosciences, Inc Industry-sponsored
Locations58 sites (Phoenix, Arizona and 57 other locations)
Trial IDNCT04950075 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial evaluates the efficacy of INBRX-109, a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5), in patients with unresectable or metastatic conventional chondrosarcoma. The study is randomized, blinded, and placebo-controlled, ensuring that the results are robust and reliable. Participants will be monitored for measurable disease progression and overall response to treatment over the course of the trial.

Who should consider this trial

Good fit: Ideal candidates include individuals with unresectable or metastatic conventional chondrosarcoma who have measurable disease and meet specific health criteria.

Not a fit: Patients with non-conventional chondrosarcoma or those who have previously been treated with DR5 agonists may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced chondrosarcoma, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies targeting DR5 have shown promise, suggesting that this approach may be effective, although this specific application in chondrosarcoma is novel.

Eligibility criteria

Show full inclusion / exclusion 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/exclusion criteria is confirmed.
6. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
7. Other exclusion criteria per protocol.

Where this trial is running

Phoenix, Arizona and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Conventional ChondrosarcomaDR5INBRX-109ApoptosisProgrammed cell death
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.