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

NCT01279603 | Completed Phase 1

• 1 other identifier: GO-2C-001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

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

Conditions

Solid Tumors

Keywords

Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

GO-203-2c

EXPERIMENTAL

Drug: GO-203-2c

Interventions

GO-203-2c DRUG

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.

GO-203-2c

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genus Oncology, LLC: lead

Study Sites (4)

TGen Clinical Research Service

Scottsdale, Arizona, 85258, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Gorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025.

  PMID: 40443562 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 19, 2011
• Study Start: January 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

US (4)