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Also known as fimepinostat
CUDC-907 · 5 trials · 24 indications
Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL)
To be evaluated in patients with relapsed and/or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). Within any given study arm, the highest dose level studied at which fewer than 2 out of 6 subjects (\< 33%) experience a dose limiting toxicity (DLT).
Number of participants with adverse events assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE, v4.0).
ORR assessments as measured using Lugano criteria.
DOR assessments as measured using Lugano criteria.
Will be analyzed using descriptive statistics from results of fimepinostat concentrations measured within the tumor tissue collected at the time of a standard of care surgery or biopsy. Within each strata, Simon's two-stage design will be used.
| 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. |
| Fimepinostat - Continuous Once Daily | EXPERIMENTAL | Fimepinostat 30-60 mg/day |
| Fimepinostat - 2x/week | EXPERIMENTAL | Fimepinostat 60-240 mg/day |
| Fimepinostat - 3x/week | EXPERIMENTAL | Fimepinostat 60-180 mg/day |
| Fimepinostat - 4x/week | EXPERIMENTAL | Fimepinosta 60-180 mg/day |
| Fimepinostat - 5x/week | EXPERIMENTAL | Fimepinostat 60-180 mg/day |
| Fimepinostat - Expansion 5x/week | EXPERIMENTAL | Fimepinostat 60 mg on the 5 days on/2 days off |
| Fimepinostat - Expansion 3x/week | EXPERIMENTAL | Fimepinostat 120 mg 3 days on/4 days off |
| Fimepinostat 60 mg - Combination w/ rituximab | EXPERIMENTAL | Fimepinostat 60 mg 5 days on.2 days off plus rituximab |
| Fimepinostat 120 mg - Combination w/ rituximab | EXPERIMENTAL | Fimepinostat 120 mg 3x/week plus rituximab |
| Fimepinostat - Biocomparability Arm | EXPERIMENTAL | Biocomparability Arm |
| Fimepinostat 30 mg - Combination w/ venetoclax | EXPERIMENTAL | Fimepinostat 30 mg 5 days on/2 days off plus venetoclax. Different combinations of dose levels for venetoclax will be explored |
| Fimepinostat 60 mg - Combination w/ venetoclax | EXPERIMENTAL | Fimepinostat 60 mg 5 days on/2 days off plus venetoclax. Different combinations of dose levels for venetoclax will be explored |
| Fimepinostat - Combination w/ venetoclax and rituximab | EXPERIMENTAL | Fimepinostat and venetoclax dosed at dose levels determined for that combination. Rituximab dosed at 375 mg/m2 IV on Day 1 of each 21 day cycle |
| Treatment (fimepinostat, tumor resection) | EXPERIMENTAL | Patients receive fimepinostat by mouth once daily, on Days -2 to 0. Within 2 hours of receiving fimepinostat on Day 0, patients undergo tumor resection or biopsy as part of their standard of care. MAINTENANCE PHASE: Patients receive fimepinostat by mouth, once daily for days 1-5 each week. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity for up to 12 months from the time treatment begins. Should patients continue to derive clinical benefit, and not experience excess toxicity or progression, patients can continue to receive drug for up to 24 months or longer pending discussion with study chairs and study sponsor. |
| Name | Type | Description |
|---|---|---|
| CUDC-907 | DRUG | - |
| fimepinostat | DRUG | - |
| Rituximab | DRUG | - |
| venetoclax | DRUG | - |
| Therapeutic Conventional Surgery | PROCEDURE | Undergo surgery |
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 oncology indications including relapsed and/or refractory diffuse large B-cell lymphoma with MYC alterations, triple-negative breast cancer, and other advanced solid tumors and lymphomas. It is being developed by Curis, Inc. and is not yet approved.
CUDC-907 is being developed by Curis, Inc., a biopharmaceutical company traded under the ticker CRIS. The drug is an investigational small molecule in clinical development for oncology indications, including lymphoma and triple-negative breast cancer.
CUDC-907 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug, meaning it is not FDA approved and remains in clinical development. Completed trials include a Phase 1 study in advanced 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 was a Phase 1 study in advanced solid tumors including triple-negative breast cancer. NCT02674750 was a Phase 2 study in relapsed or refractory diffuse large B-cell lymphoma with MYC alterations. NCT02909777 was a Phase 1 study in children and young adults with relapsed or refractory solid tumors or lymphoma.
CUDC-907 is also known as fimepinostat. It is an investigational small molecule being developed by Curis, Inc. for oncology indications. The drug has been evaluated in clinical trials for lymphoma, triple-negative breast cancer, and other solid tumors.