Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Subjects With Advanced/Relapsed Solid Tumors

Study Overview
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Brief Summary
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This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors.

Detailed Description
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This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors. The following dosing schedule, consisting of 21-day treatment cycles, is being examined: Five days on/two days off on Days 1 to 5, 8 to 12, and 15 to 19 (5/2 schedule).

Official Title
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Phase I Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, an HDAC and PI3K Inhibitor, in Subjects With Advanced/Relapsed Solid Tumors

Conditions
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Solid Tumors, Triple-Negative Breast Cancer, High-grade Serous Ovarian Cancer, NUT Midline Carcinoma

Intervention / Treatment
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* Drug: CUDC-907


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ≥18 years of age for solid tumor; in the case of midline carcinoma with NUT rearrangement. subjects may be ≥16 years of age. Histopathologically confirmed diagnosis of an advanced solid tumor such as breast cancer or midline carcinoma with NUT rearrangement, that has progressed despite standard therapy, or for which no standard therapy exists. For enrollment in the expansion cohorts, histopathological confirmation of triple-negative breast cancer or high-grade serous ovarian cancer is required. Measurable or evaluable disease. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments or radiotherapy (excluding alopecia). Exclusion Criteria: Systemic anticancer therapy within three weeks of study entry, except for nitrosoureas or mitomycin C within six weeks. Radiotherapy within one week prior to starting study treatment. Other investigational agent(s) within 21 days prior starting to study treatment. Symptomatic central nervous system (CNS) involvement or lymphangitic metastasis. Stable or improving CNS disease that is not under active treatment after receipt of adequate therapy is allowed. Uncontrolled or severe cardiovascular disease, including myocardial infarction or unstable angina within six months prior to study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease or cardiac amyloidosis.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CUDC-907 - five days on/two days off<br>60 mg/day CUDC-907, oral administration, five days on/two days off until disease progression or other discontinuation criteria are met. | Drug: CUDC-907<br>* CUDC-907 oral with meals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors |  | 21 day cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC). |  | 21 day cycle | 
| To evaluate biomarkers of CUDC-907 activity |  | 24 months | 
| To assess the preliminary anti-cancer activity of CUDC-907 | The Investigator will evaluate each subject for response to therapy according to standard response criteria for each individual subject's tumor type | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TNBC, HGSOC, NMC