Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GO-203-2c | Drug | MUC1-targeted Peptide GO-203-2C | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GO-203-2c
- interventionNames
- Drug: GO-203-2c
Primary outcomes (1)
- measure
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- 24 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGorodetska 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