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

Genus Oncology, LLC4 sites in 1 country23 target enrollmentJanuary 2011

ConditionsSolid Tumors

InterventionsGO-203-2c

DrugsGO-203-2c

Overview

Phase: Phase 1
Intervention: GO-203-2c
Conditions: Solid Tumors
Sponsor: Genus Oncology, LLC
Enrollment: 23
Locations: 4
Primary Endpoint: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

May 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genus Oncology, LLC

Responsible Party

Sponsor

Eligibility Criteria

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)

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
•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)

Arms & Interventions

GO-203-2c

Intervention: GO-203-2c

Outcomes

Primary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time Frame: 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