High-grade Serous Ovarian Cancer, NUT Midline Carcinoma, Solid Tumors, Triple-Negative Breast Cancer
Conditions
Keywords
TNBC, HGSOC, NMC
Brief summary
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
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).
Interventions
DRUGCUDC-907
CUDC-907 oral with meals.
Sponsors
Curis, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects ≥18 years of age for solid tumor; in the case of midline carcinoma with NUT rearrangement. subjects may be ≥16 years of age. 2. 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. 3. Measurable or evaluable disease. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments or radiotherapy (excluding alopecia).
Exclusion criteria
1. Systemic anticancer therapy within three weeks of study entry, except for nitrosoureas or mitomycin C within six weeks. 2. Radiotherapy within one week prior to starting study treatment. 3. Other investigational agent(s) within 21 days prior starting to study treatment. 4. 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. 5. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors | 21 day cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 24 months | The Investigator will evaluate each subject for response to therapy according to standard response criteria for each individual subject's tumor type |
Countries
United States
Outcome results
None listed