Study of GO-203-2C Given Intravenously in Patients With Advanced Solid Tumors Including Lymphomas
- Registration Number
- NCT01279603
- Lead Sponsor
- Genus Oncology, LLC
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GO-203-2c GO-203-2c -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
TGen Clinical Research Service
🇺🇸Scottsdale, Arizona, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Texas Health Science Center San Antonio
🇺🇸San Antonio, Texas, United States