Drugs / OZEKIBART
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03715933 | Oct 2018 → Dec 2028 expected | Ewing sarcoma, colorectal adenocarcinoma | Inhibrx Biosciences, Inc | Recruiting | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT04950075 | Sep 2021 → Sep 2025 overdue | chondrosarcoma | Inhibrx Biosciences, Inc | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-06-15 | Inhibrx Biosciences, Inc | Regulatory Inhibrx Announces U.S. FDA Acceptance of BLA for Ozekibart in Patients with Conventional Chondrosarcoma investorroom.com ↗ |
| 2026-05-21 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Transcenta’s Partner Inhibrx Reports Positive Updated CRC Data for Ozekibart and Announces U.S. BLA Submission for Chondrosarcoma transcenta.com ↗
According to Inhibrx, the updated interim data demonstrated encouraging anti-tumor activity and a manageable safety profile in a heavily pretreated CRC patient population. |
| 2026-04-21 | Inhibrx Biosciences, Inc | Results Inhibrx Provides Clinical Update on Ozekibart (INBRX-109) in Late Line Colorectal Cancer investorroom.com ↗
Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel biologic therapeutic candidates, today announced updated interim data from its Phase 1/2 study evaluating ozekibart (INBRX-109) in combination with FOLFIRI in patients with locally advanced or metastatic, unresectable colorectal cancer (CRC). |
| 2025-10-31 | Transcenta Therapeutics (Hangzhou) Co., Ltd. | Results Transcenta’s Partner Inhibrx Reports Positive Phase 2 Results for Ozekibart in Chondrosarcoma, with a BLA Submission Planned for 2026 transcenta.com ↗
Ozekibart is the first investigational therapy to demonstrate a significant PFS benefit in a randomized trial for chondrosarcoma, a disease with no approved systemic options. |
| 2025-10-23 | Inhibrx Biosciences, Inc | Results Inhibrx Biosciences Reports Positive Topline Results from its Registrational Trial of Ozekibart (INBRX-109) in Chondrosarcoma and Provides Updates on Colorectal Cancer and Ewing Sarcoma Expansion Cohorts investorroom.com ↗
The ChonDRAgon study met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival (PFS) for patients with advanced or metastatic chondrosarcoma treated with ozekibart compared to placebo. |
| 2025-01-21 | Inhibrx Biosciences, Inc | Results Inhibrx Biosciences Announces Preliminary Data from the Phase 1 Trial of ozekibart (INBRX-109) for the Treatment of Colorectal Cancer investorroom.com ↗
Results demonstrated one complete response (CR), three partial responses (PR), and six cases of stable disease (SD). |
| 2023-11-02 | Inhibrx Biosciences, Inc | Results Inhibrx Announces Preliminary Data from the Phase 1 Trial of INBRX-109 for the Treatment of Ewing Sarcoma investorroom.com ↗
Among the 13 patients evaluable, which included 7 classical Ewing sarcoma patients (EWS) and 6 round cell sarcoma patients (RCS), the observed disease control rate was 76.9%, or 10 out of 13 patients as measured by RECISTv1.1. |
| 2023-04-26 | Inhibrx Biosciences, Inc | Regulatory Inhibrx Initiates a Registration-Enabling Trial of INBRX-101 in AATD and Announces Lift of Partial Clinical Hold on INBRX-109 DR5 Agonist Trials investorroom.com ↗
Additionally, the Company announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on studies evaluating its death-receptor 5 (DR5) agonist, INBRX-109. |
| 2022-11-16 | Inhibrx Biosciences, Inc | Results Inhibrx Announces Updated Efficacy and Safety Data from the Expansion Cohorts in the Phase 1 Trial of INBRX-109 for the Treatment of Chondrosarcoma investorroom.com ↗
To date, the median progression-free survival (PFS) is 7.6 months, and five patients remain on study. |
| 2022-08-15 | Inhibrx Biosciences, Inc | Regulatory European Medicines Agency Grants Orphan Drug Designation to INBRX-109 for the Treatment of Chondrosarcoma investorroom.com ↗
Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and a strong emerging pipeline, today announced that the European Commission ("EC"), based on a positive opinion issued by the European Medicines Agency ("EMA"), has granted orphan medicinal product designation to INBRX-109 for the treatment of chondrosarcoma. |
| 2021-12-01 | Inhibrx Biosciences, Inc | Regulatory Inhibrx Receives FDA Orphan-Drug Designation for INBRX-109 in Chondrosarcoma investorroom.com ↗
Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and a strong emerging pipeline, today announced that the U.S. Food and Drug Administration, or FDA, has granted orphan-drug designation for INBRX-109 for the treatment of chondrosarcoma. |
| 2021-01-13 | Inhibrx Biosciences, Inc | Regulatory Inhibrx Granted Fast Track Designation for INBRX-109 for the Treatment of Unresectable or Metastatic Conventional Chondrosarcoma Patients investorroom.com ↗
Inhibrx, Inc. (Inhibrx), a clinical-stage biotechnology company with a broad pipeline of biotherapeutics in development, announced today the U.S. Food and Drug Administration (FDA) granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma. |
| 2020-11-11 | Inhibrx Biosciences, Inc | Results Inhibrx Announces Positive Interim Results from the Phase 1 Trial of INBRX-109 in Chondrosarcoma Patients investorroom.com ↗
Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development, announced updated interim results today from a Phase 1 clinical trial evaluating the efficacy and safety of INBRX-109 in patients with chondrosarcoma. |
| 2019-09-03 | Inhibrx Biosciences, Inc | Results Inhibrx Reports Phase 1 Dose Escalation Results of INBRX-109, a Multivalent Agonist of Death Receptor 5 investorroom.com ↗
Initial signs of disease control were demonstrated in five out of eight (5/8) patients with the tumor types chosen for inclusion in the expansion cohorts. |
All press releases naming this drug 19 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OZEKIBART | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314613 ↗ |
| Known as | INBRX-109 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03715933 ↗ |
| Action | Activate | “INBRX-109, a third-generation death receptor 5 (DR5) agonist” PMID 37265425 ↗ Aug 2023 |
| Modality | Monoclonal antibody | — CHEMBL5314613 ↗ |
| Route | Intravenous | “IV every three weeks” NCT04950075 ↗ |