Solid Tumors
Conditions
Keywords
Cancer
Brief summary
This clinical trial is about testing GO-203-2c, which is a newly discovered compound that binds to an oncoprotein (a cancer causing protein) called MUC1 (which is over-expressed in many cancers). By binding to MUC1, GO-203-2c eventually causes tumor cell death in laboratory studies. This study is being done to: * Test the safety of GO-203-2c and see what effects (good and bad) it has on you and your cancer * Find the highest dose of GO-203-2c that can be given without causing bad side effects * Examine how much GO-203-2c is in the blood at certain times after it is given and how quickly the body gets rid of it * Observe whether there is any effect of GO-203-2c on the size and activity of cancer in your body
Interventions
DRUGGO-203-2c
GO-203-2c Injection is a non-preserved, sterile, ready-to-use liquid dosage form provided in a glass vial with rubber closure and crimp seal. Injection will be added to the contents of an intravenous bag (of 0.9% NS, D5W or sterile water) to a final concentration of between 0.03 - 0.3 mg/ml (preferable in 100 mls or greater) and administered as a single agent intravenously over 60 minutes. A treatment cycle will consist of a daily IV dose administered for 21 consecutive days followed by a 7 day rest.
Sponsors
Genus Oncology, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed solid tumors or lymphomas * Tumor progression observed after receiving standard/approved systemic chemotherapy and/or immunotherapy including monoclonal antibodies, or when there is no approved or effective therapy * One or more measureable tumors by radiological evaluation * Karnofsky performance ≥ 70% * Life expectancy of ≥ 3 months * Age ≥ 18 years * Signed, written IRB-approved informed consent * Negative pregnancy test (if female) * Adequate liver function: * Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) * AST (SGOT), ALT (SGPT) and Alkaline phosphatase less than or equal to 2.5 x ULN (if liver metastases are present, then less than or equal to 5 x ULN is allowed) * Adequate renal function: * Serum creatinine within normal limits, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine above institutional ULN. * Corrected serum calcium ≥ lower limit of the institutional normal range (LLN) * Serum phosphorus level ≥ LLN * Adequate hematologic function: * Absolute Neutrophil Count ≥ 1500 cells/mm3 * Platelet count ≥ 100,000 (cells/mm3) * Hemoglobin ≥ 9 g/dL * Urinalysis: * No clinically significant abnormalities * Adequate coagulation function: * PT ≤ 1.25 x ULN * PTT ≤ 1.25 x ULN * For men and women of child-producing potential, agreement to use effective contraceptive methods during the study
Exclusion criteria
* New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG * Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy * Pregnant or nursing women. NOTE: Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. * Major surgery within 4 weeks prior to Day 1, or not fully recovered by Day 1 * Minor surgery within 2 weeks prior to Day 1, or not fully recovered by Day 1 * Treatment with radiation therapy within 4 weeks prior to Day 1. * Received systemic chemotherapy or monoclonal antibody or other immunotherapy within 4 weeks prior to Day 1 (exceptions: 6 weeks for nitrosourea, mitomycin C, or any agent with a known treatment effect \> 4 weeks' duration), or not fully recovered from any side effects from previous therapy by Day 1 * History of allergic reactions attributed to excipients or chemical products used in the final GO-203-2c drug formulation * Known infection with HIV, hepatitis B, or hepatitis C. * Subjects with risk factors for gastrointestinal perforation or pulmonary hemorrhage (e.g. unresected luminal intestinal cancers; abdominal carcinomatosis within 3 months before the first dose of study drug, abdominal fistula, acute diverticulitis, peptic ulcer disease, irritable bowel syndrome, Crohn's disease, pulmonary hemorrhage, hemoptysis, or tuberculosis) * Currently receiving or having received treatment with any other investigational agent within 4 weeks prior to Day 1, or not fully recovered from toxicities of prior treatment by Day 1 * Serious and/or poorly controlled non-malignant disease (including but not limited to, ongoing or active infection, hydronephrosis, hypertension, diabetes, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the sponsor. Patients with such conditions should be discussed with the Medical Monitor prior to enrollment. All medical conditions must be NCI CTCAE Grade 1 or lower at baseline. * Unwillingness or inability to comply with requirements of this protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 24 months | To determine the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) of GO-203-2c - To establish the dose of GO-203-2c recommended for future phase II protocols |
Countries
United States
Outcome results
None listed