Study of PM060184 in Patients With Advanced Solid Tumors

Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors

The purpose of the study is to determine the maximum tolerated dose and the recommended dose and to evaluate the safety and tolerability of PM060184.

This trial intends to determine the maximum tolerated dose and the recommended dose, to evaluate the safety and tolerability, to determine the pharmacokinetics and to evaluate the antitumor activity of PM060184 in patients with advanced solid tumors.

Inclusion criteria

1. Voluntary signed and dated written informed consent.
2. Patients with advanced solid tumors refractory to Standard therapy.
3. Age >/= 18 years.
4. Recovery from drug-related adverse events (AEs) of previous treatments, excluding alopecia.
5. Normal laboratory values within seven days prior to treatment administration.
6. Women of childbearing potential must have a negative serum pregnancy test before study entry. Both men and women must agree to use a medically acceptable method of contraception throughout the treatment period and for three months after discontinuation of treatment.

Exclusion criteria

1. Pregnant or lactating women.

2. Less than three weeks from radiation therapy or last dose of hormonal therapy, biological therapy or chemotherapy

3. Prior treatment with any investigational product less than 30 days prior to the first.

4. Central Nervous System metastases

5. Other relevant diseases or adverse clinical conditions:

   • Increased cardiac risk:
   • Presence of significant neurological or psychiatric disorders
   • Neuropathy
   • Active infection requiring treatment.
   • Liver disease (e.g., cirrhosis, hepatitis).
   • Immunocompromised patients.
   • Any other major illness.

6. Limitation of the patient's ability to comply with the treatment.

7. Known hypersensitivity to any of the components of the drug product.