Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CUDC-101 · 3 trials · 6 indications
Safety and tolerability will be assessed by evaluating the number of patients with adverse events
Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.
The maximum tolerated dose is the highest dose level at which \<33% of at least 6 or more subjects experiences a dose limiting toxicity.
The number of patients with adverse events will be assessed to determine the safety and tolerability of CUDC-101.
| Arm | Type | Description |
|---|---|---|
| Arm A: 5 days/week schedule | EXPERIMENTAL | - |
| Arm B: 3 days/week schedule | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CUDC-101 | DRUG | CUDC-101 will be administered as a 1 hour intravenous infusion three times per week for a one week run-in (week -1) and then as part of the combination treatment on weeks 1-7. If the 225 mg/m2 dose is tolerated in the first cohort, the dose will be increased to 275 mg/m2. If the 225 mg/m2 dose is not tolerated, the dose will be decreased to 175 mg/m2. If 175 mg/m2 is not tolerated the dose will be further decreased to 150 mg/m2. |
| Cisplatin | DRUG | Cisplatin will be administered intravenously at a dose of 100 mg/m2 on days 2, 23 and 44 of the seven week combination treatment course. |
| Radiation Therapy | RADIATION | The initial target volume encompassing the gross and subclinical disease sites will receive 2.0 Gy per fraction, five fractions per week. The gross disease sites will receive 70 Gy in 35 fractions over seven weeks and the subclinical disease sites will receive 56 Gy in 35 fractions, again over seven weeks. |
Inclusion Criteria: * Subjects with locally advanced, pathologically confirmed diagnosis of squamous cell carcinoma of the head and neck at the following sites: oral cavity, oropharynx, hypopharynx and larynx with either: * Stage IV p16 positive tumors and \>10 pack-years smoking history. * St...
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CUDC-101 is an investigational small molecule being studied for the treatment of head and neck cancer and other advanced solid tumors. It has been evaluated in Phase 1 clinical trials that included patients with head and neck, gastric, breast, liver, and non-small cell lung cancers.
CUDC-101 is a small molecule inhibitor that targets EGFR and histone deacetylases (HDAC1, HDAC2, HDAC3, HDAC5, and HDAC6). By inhibiting these targets, it is designed to interfere with multiple signaling pathways involved in tumor growth and survival.
CUDC-101 is being developed by Curis, Inc., a biotechnology company that trades on the Nasdaq under the ticker symbol CRIS. Curis is responsible for the clinical development of the drug.
CUDC-101 is in Phase 1 clinical development. It has not been approved by the FDA and remains an investigational agent. All reported trials of CUDC-101 are Phase 1 studies, and no later-phase trials have been registered.
CUDC-101 has been studied in three completed Phase 1 trials: NCT01384799 in head and neck cancer with cisplatin and radiation, NCT01171924 in advanced head and neck, gastric, breast, liver, and non-small cell lung cancers, and NCT00728793 in advanced solid tumors.
CUDC-101 is a distinct small molecule that inhibits both EGFR and HDAC enzymes. It is not the same as other HDAC inhibitors; it is a dual-acting agent developed specifically by Curis, Inc. under the name CUDC-101.