Study of GO-203-2C Given Intravenously in Patients With Advanced Solid Tumors Including Lymphomas

A Phase 1, Multi-center, Open-label, Dose-escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GO-203-2c Given Intravenously Daily X21 Repeated Every 28 Days in Patients With Advanced Solid Tumors Including Lymphomas

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

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: GO-203-2c

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • TGen Clinical Research Service
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: GO-203-2c

Drug: GO-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	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	24 months

Collaborators and Investigators

• Sponsor: Genus Oncology, LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: January 11, 2011
• First Submitted That Met QC Criteria: January 18, 2011
• First Posted (Estimate): January 19, 2011

Study Record Updates

• Last Update Posted (Estimate): September 19, 2014
• Last Update Submitted That Met QC Criteria: September 18, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Cancer
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Neoplasms; Lymphoma
• Other Study ID Numbers: GO-2C-001