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CUDC-907 · 3 trials · 9 indications
Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL)
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Group A: MYC translocation+ and/or MYC gene copy number gain by FISH |
| Group B | EXPERIMENTAL | Group B: MYC expression in \> 40% of tumor cells by IHC |
| Group C | EXPERIMENTAL | Group C: MYC translocation- by FISH, and MYC expression in \< 40% of tumor cells, and no MYC gene copy number gain by FISH |
| CUDC-907 | EXPERIMENTAL | * CUDC-907 orally administered * CUDC-907 once daily for 5 consecutive days per week followed by two days without dosing * Dose level assigned at registration * Pre-dose pharmacokinetic blood sample will be collected * Dose escalation will follow a standard 3+3 design |
| CUDC-907 - five days on/two days off | EXPERIMENTAL | 60 mg/day CUDC-907, oral administration, five days on/two days off until disease progression or other discontinuation criteria are met. |
| Name | Type | Description |
|---|---|---|
| CUDC-907 | DRUG | - |
Inclusion Criteria: 1. Age ≥ 18 years. 2. At least 2 but no more than 4 prior lines of therapy for the treatment of de novo DLBCL and ineligible for (or failed) autologous or allogeneic stem cell transplant (SCT) (salvage therapy, conditioning therapy and maintenance with transplant will be conside...
CUDC-907 is an investigational small molecule being studied for the treatment of several cancers, including triple-negative breast cancer, lymphoma, and relapsed and/or refractory diffuse large B-cell lymphoma, including cases with MYC alterations. It has also been evaluated in solid tumors, ovarian cancer, NUT midline carcinoma, neuroblastoma, and brain tumors.
CUDC-907 is being developed by Curis, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CRIS. The company has sponsored clinical trials of the drug in patients with advanced cancers.
CUDC-907 is an investigational drug that has completed Phase 1 and Phase 2 clinical trials. It is not FDA approved and remains in clinical development. The completed trials include a Phase 1 study in solid tumors and a Phase 2 study in relapsed or refractory diffuse large B-cell lymphoma.
CUDC-907 has been studied in three completed clinical trials: NCT02307240, a Phase 1 study in advanced or relapsed solid tumors; NCT02674750, a Phase 2 study in relapsed or refractory diffuse large B-cell lymphoma with MYC alterations; and NCT02909777, a Phase 1 study in children and young adults with relapsed or refractory solid tumors, CNS tumors, or lymphoma.
CUDC-907 is a small molecule that targets specific proteins involved in cancer cell growth. It is designed to inhibit these targets, which may help slow or stop the growth of cancer cells. The drug is being studied in biomarker-selected patient populations, such as those with MYC alterations.