Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INBRX-109 · 2 trials · 3 indications
Progression-free survival per RECISTv1.1 will be determined.
Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Evaluating how the tumor responds to treatment by measuring the number of patients with colorectal cancer and Ewing sarcoma that experience tumor shrinkage and for how long.
| Arm | Type | Description |
|---|---|---|
| INBRX-109 | EXPERIMENTAL | IV every three weeks |
| Placebo | PLACEBO_COMPARATOR | IV every three weeks |
| Dose Escalation (Complete) | EXPERIMENTAL | INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas. |
| Expansion Malignant Pleural Mesothelioma (Complete) | EXPERIMENTAL | Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D. |
| Expansion Gastric Adenocarcinoma (Complete) | EXPERIMENTAL | Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D. |
| Expansion Colorectal Adenocarcinoma (Complete) | EXPERIMENTAL | Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D. |
| Expansion Sarcomas (Complete) | EXPERIMENTAL | Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D. |
| Combination Expansion Malignant Pleural Mesothelioma (Complete) | EXPERIMENTAL | Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed) |
| Combination Expansion Pancreatic Adenocarcinoma (Complete) | EXPERIMENTAL | Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy |
| Combination Expansion Adult Ewing Sarcoma | EXPERIMENTAL | Adult subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide |
| Combination Expansion Colorectal Adenocarcinoma (Complete) | EXPERIMENTAL | Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy |
| Expansion Solid Tumors (Complete) | EXPERIMENTAL | Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D. |
| Combination Expansion SDH-deficient solid tumors or GIST (Complete) | EXPERIMENTAL | Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide |
| Combination Expansion Colorectal Adenocarcinoma patients with FOLFIRI plus bevacizumab | EXPERIMENTAL | Colorectal adenocarcinoma will be treated with INBRX-109 with FOLFIRI (FU, leucovorin, and irinotecan) plus bevacizumab |
| Combination Expansion Colorectal Adenocarcinoma with FTD/TPI plus bevacizumab | EXPERIMENTAL | Colorectal adenocarcinoma will be treated with INBRX-109 with FTD/TPI plus bevacizumab |
| Combination Expansion Adolescent Ewing Sarcoma | EXPERIMENTAL | Adolescent (12 to \<18) subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide |
| Name | Type | Description |
|---|---|---|
| INBRX-109 | DRUG | Tetravalent DR5 Agonist Antibody |
| Placebo | DRUG | Placebo |
| Irinotecan | DRUG | Chemotherapy |
| Temozolomide | DRUG | Chemotherapy |
| carboplatin | DRUG | chemotherapy |
| pemetrexed | DRUG | chemotherapy |
| Leucovorin | DRUG | chemotherapy |
| Fluorouracil | DRUG | chemotherapy |
| Bevacizumab | DRUG | targeted therapy |
| Trifluridine + Tipiracil | DRUG | chemotherapy |
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 progre...
INBRX-109 is an investigational small molecule being developed for the treatment of conventional chondrosarcoma and Ewing sarcoma. It is currently in Phase 2 clinical development for these oncology indications.
INBRX-109 targets DR5, a death receptor involved in apoptosis. By engaging DR5, the drug is designed to trigger cell death in tumor cells, which is relevant for its potential use in sarcomas.
INBRX-109 is being developed by Inhibrx Biosciences, Inc., a biopharmaceutical company traded under the ticker INBX. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
INBRX-109 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Its safety and efficacy are still being evaluated in clinical trials.
INBRX-109 is being studied in two clinical trials. NCT03715933 is a Phase 1 study in solid tumors including sarcomas, and NCT04950075 is a Phase 2 study in conventional chondrosarcoma. Both trials are active.
INBRX-109 is the primary name for this investigational drug. No alternative names have been reported for it in clinical development.