A Phase I/II Trial of the MUC1 Inhibitor, GO-203-2C in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia, in Relapse, Recurrent Adult Acute Myeloid Leukemia

In brief

This research study is studying a targeted therapy known as GO-203-2C as a possible treatment for with acute myeloid leukemia (AML) both alone and in combination with decitabine. GO-203-2c targets cancer cells, while leaving healthy cells unaffected.This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies.

Key facts

Study ID

NCT02204085

Run by

Beth Israel Deaconess Medical Center

People needed

33

Starts

2014-09-01

Expected to finish

2025-12-01

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be considered eligible for enrollment into this study, all of the following inclusion criteria must be met during the screening period:
• Documented AML by peripheral blood and bone marrow analyses meeting WHO criteria, excluding patients with acute promyelocytic leukemia (APL)
• Patients with AML refractory to primary induction chemotherapy, relapsed disease, or age ≥ 60 and not appropriate for standard cytotoxic therapy due to age, performance status, and/or adverse risk factors according to the treating physician
• Age ≥ 18 years
• Karnofsky performance status ≥ 50% or ECOG performance status 0-2
• Life expectancy ≥ 6 weeks
• Able to understand the investigational nature of this study and to provide written consent to participate in it
• Signed written IRB-approved Informed Consent document
• Adequate hepatic and renal function:
• serum bilirubin ≤ 1.5 X institutional ULN OR serum direct bilirubin ≤ 2 X institutional ULN
• serum ALT and AST ≤ 2.5 X institutional ULN
• serum alkaline phosphatase < 5 X institutional ULN
• serum creatinine ≤ 2.0 mg/dL
• corrected calcium level ≥ institutional LLN
• Negative pregnancy test in women of child-bearing potential
• Women and men of child-producing potential must agree to use effective contraceptive methods during the study period (including post-treatment observation period)

You may not qualify if…

• A patient will be considered not eligible for enrollment into this study if any of the following criteria are met during the screening period:
• Evidence of leukemic meningitis or other CNS involvement by leukemia
• Uncontrolled or poorly controlled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg) Note: an isolated reading that is not sustained will be permitted.
• Evidence of NYHA Class III or IV cardiac disease, or presence of unstable life-threatening arrhythmia, or history of myocardial infarction during the past 6 months
• Active bacterial, fungal, or viral infection requiring systemic treatment
• Known infection with HIV
• History or major surgery within 4 weeks before the first dose of study treatment, or not recovered from prior surgery
• Exposure to any other investigational agent at any time within 4 weeks before the first dose of study treatment
• Exposure to any other anti-leukemic therapy (except hydroxyurea, see Section 5.5.1) within 2 weeks before the first dose of study treatment
• Pregnant or lactating female
• Unwilling or unable to comply with the requirements of the study protocol

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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