An Open-Label Phase 1 Study to Investigate the Safety and Maximum Tolerated Dose of INNO-206 (Doxorubicin-6-Maleimidocaproyl Hydrazone; DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors
- Age between 18 and 70 years, male or female.
- Histologically or cytologically confirmed malignant solid tumor that has relapsed or
is refractory to standard therapy.
- Subjects who have received prior radiation therapy with stable CNS metastasis with no
progression of brain metastasis by CT/MRI scan in last 4 weeks.
- Capable of providing informed consent and complying with trial procedures.
- ECOG performance status 0-2.
- Life expectancy >12 weeks.
- Measurable or evaluable disease according to RECIST 1.1 criteria.
- Women must not be able to become pregnant (e.g. post menopausal for at least 1 year,
surgically sterile, or practicing adequate birth control methods) for the duration of
- Women of child bearing potential must have a negative serum or urine pregnancy test
at the Screening Visit and be non-lactating.
- Geographic accessibility to the site.
- Palliative surgery, chemotherapy, immunotherapy and/or radiation less than 4 weeks
prior to the Screening Visit.
- Exposure to any investigational agent within 30 days of the Screening Visit.
- Laboratory values: Screening serum creatinine greater than or equal to 1.5 mg/dL,
alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total
bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC)
count < 3500/mm3, absolute neutrophil count < 2000/mm3, platelet concentration <
100,000/mm3, hematocrit level < 33% for females or < 35% for males, or coagulation
tests (PT,PTT) >1.5 times the upper limit or normal.
- Clinically evident congestive heart failure > class II of the New York Heart
Association (NYHA) guidelines.
- Serious, clinically significant cardiac arrhythmias, defined as the existence of an
absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
- History or signs of active coronary artery disease with or without angina pectoris.
- Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial
scintigram)or ultrasound determined absolute left ventricular ejection fraction
(LVEF) < 45% of predicted.
- History of HIV infection.
- Active, clinically significant serious infection requiring treatment with
antibiotics, antivirals or antifungals.
- Major surgery within 3 weeks prior to treatment.
- Substance abuse or any condition that might interfere with the subject's
participation in the study or in the evaluation of the study results.
- Any condition that is unstable and could jeopardize the subject's participation in