INNO-105 in Patients With Solid Tumors

A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Weekly Intravenous INNO-105 in Adult Patients With Advanced Solid Malignancies

The safety, tolerability and pharmacokinetics of INNO-105, an investigational anticancer drug, are being studied in patients with solid tumors.

Inclusion Criteria:

1. Have a histologically or cytologically confirmed diagnosis of a solid malignancy (patients may have either measurable or nonmeasurable disease).
2. Be ≥18 years old.
3. Not eligible for effective therapy likely to provide clinical benefit.
4. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
5. Acceptable pretreatment clinical laboratory results.
6. Life expectancy of greater than 12 weeks.

Exclusion Criteria:

1. Have received previous treatment with INNO-105.
2. Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
3. Are pregnant or lactating.
4. Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
5. Have received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in this study.
6. Have not recovered from acute toxicity of all previous therapy prior to enrollment.
7. Have symptomatic or untreated central nervous system (CNS) metastases.
8. Have a susceptibility to hypotension, bradycardia, and/or hypopnea, such as patients with known coronary heart disease, arrhythmias, cerebral vascular disease, and chronic obstructive airways disease (CO2-retaining).