Phase I Multicenter, Open-label, Dose-escalating Clinical and Pharmacokinetic Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors

Inclusion Criteria:

- Voluntary written informed consent form.

- Histologically or cytologically confirmed advanced malignant solid tumors.

- Measurable or non-measurable disease following (RECIST)

- Age ≥ 18 years.

- Life expectancy ≥ 3 months.

- Performance status ECOG ≤ 2.

- Recovery from any drug-related adverse events (AEs) derived from previous treatments.

- Appropriate bone marrow, liver and renal function.

- Left ventricular ejection fraction (LVEF) within normal limits for the institution.

- 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:

- Prior therapy with PM02734.

- Pregnant or lactating women.

- Less than four weeks from radiation therapy.

- Evidence of progressive central nervous system (CNS) metastases. or any symptomatic
brain or leptomeningeal metastases.

- Other relevant diseases or adverse clinical conditions.

- Any other major illness that, in the Investigator's judgment.

- Limitation of the patient's ability to comply with the treatment or to follow-up at a
participating protocol.

- Ingestion of potent cytochrome CYP3A4 inhibitors.

- Treatment with any investigational product in the 30-day period prior to the first
infusion.

- Known hypersensitivity to any component of PM02734 or erlotinib.