Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ENMD-2076 · 6 trials · 9 indications
6-month overall response rate (ORR rate) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) - disappearance of all target lesions; partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; ORR = proportion of patients evaluated as CR + PR
| Arm | Type | Description |
|---|---|---|
| ENMD-2076 | EXPERIMENTAL | ENMD-2076, oral capsule Once daily dose 250 mg/day |
| ENMD-2076 Treatment | EXPERIMENTAL | ENMD-2076 |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | Advanced cancer, excluding patients with colorectal or ovarian cancers |
| 3 | EXPERIMENTAL | Recurrent or resistant epithelial ovarian cancer |
| 4 | EXPERIMENTAL | Colorectal cancer patients who have progressed and/or failed on irinotecan- and oxaliplatin-based regimens |
| Name | Type | Description |
|---|---|---|
| ENMD-2076 | DRUG | 250 mg oral dose, once daily (QD) for 28 day cycles |
Inclusion Criteria: * Histologically or cytologically confirmed advanced fibrolamellar carcinoma (FLC). * All forms of prior local therapy are allowed as long as patients have either a target lesion, which has not been treated with local therapy and/or the target lesion(s) within the field of the l...
ENMD-2076 is an investigational oral small molecule being studied in several cancer types, including advanced fibrolamellar and adult hepatocellular carcinoma, triple negative breast cancer, ovarian cancer, and relapsed or refractory hematological malignancies. It is not approved for any indication and remains in clinical development.
ENMD-2076 is a kinase inhibitor that targets FGFR3, AURKA, AURKB, CSF1R, KIT, and FLT3. By inhibiting Aurora kinases and angiogenic kinases such as FGFR3 and CSF1R, the drug is designed to interfere with tumor cell division and blood vessel formation in advanced cancers.
ENMD-2076 is being developed by CASI Pharmaceuticals, Inc., which trades under the ticker CASI. The company has sponsored the clinical program evaluating the compound across solid tumors and hematological malignancies.
ENMD-2076 is in Phase 2 development. It has been evaluated in completed Phase 2 studies in fibrolamellar carcinoma, triple negative breast cancer, and ovarian cancer, plus a completed Phase 1 study in relapsed or refractory hematological malignancies. It is investigational and has not been approved by the FDA.
Completed trials include NCT02234986 in advanced fibrolamellar carcinoma, NCT01639248 in previously treated metastatic triple negative breast cancer, NCT01104675 in ovarian, fallopian, and peritoneal cancer, and NCT00904787 in relapsed or refractory hematological malignancies. All four studies have finished, and no trials are currently active.
Yes. ENMD-2076 and ENMD 2076 refer to the same investigational compound from CASI Pharmaceuticals. The hyphenated form is the standard spelling used in study records and publications, while the unhyphenated version appears in some search queries and informal references.