Approval Probability
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Fimepinostat · 2 trials · 16 indications
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 |
|---|---|---|
| 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 |
|---|---|---|
| fimepinostat | DRUG | - |
| Rituximab | DRUG | - |
| venetoclax | DRUG | - |
| Therapeutic Conventional Surgery | PROCEDURE | Undergo surgery |
Inclusion Criteria: * Patients ≥ 18 years of age with any of the following: Histopathologically confirmed DLBCL or HGBL (i.e., HGBL with MYC, BCL2, and/or BCL6 rearrangements, HGBL, not otherwise specified \[NOS\], or DLBCL, NOS) that is refractory to, or has relapsed after, treatment with at least...
Fimepinostat is an investigational small molecule being studied for the treatment of lymphoma and diffuse intrinsic pontine glioma (DIPG). It is in Phase 1 clinical development for these oncology indications.
Fimepinostat is an inhibitor that targets multiple HDAC enzymes, including HDAC1, HDAC2, HDAC3, HDAC4, HDAC5, HDAC6, HDAC7, HDAC8, HDAC9, HDAC10, and HDAC11, as well as PIK3CA, PIK3CB, and PIK3CD.
Fimepinostat is being developed by Curis, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CRIS.
Fimepinostat is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing or completed to assess its safety and efficacy.
Fimepinostat has been studied in two clinical trials. NCT01742988, a completed Phase 1 study in patients with lymphoma, enrolled 106 participants. NCT03893487, an early Phase 1 study in children and young adults with brain tumors including DIPG, is active but not recruiting.
Yes, Fimepinostat is also known as CUDC-907. In clinical trial NCT01742988, the drug is referred to as Fimepinostat (CUDC-907), confirming that these names refer to the same compound.