Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

Inclusion Criteria:

- Age ≥ 18 years.

- Voluntary signed informed consent (IC)

- Pathologically proven diagnosis of any of the following malignancies:

- Small cell lung cancer (SCLC).

- Head and neck carcinoma (H&N). Salivary glands tumors are excluded.

- Neuroendocrine tumors (NETs), grade 2 and grade 3 according to World Health
Organization classification.

- Biliary tract carcinoma.

- Endometrial carcinoma.

- BRCA 1/2- associated metastatic breast carcinoma

- Carcinoma of unknown primary site.

- Germ cell tumor (GCTs), excluding immature teratoma, or teratoma with malignant
transformation.

- Ewing's family of tumors (EFTs)

- Prior treatment. Patients must have received:

- SCLC, endometrial carcinoma: one prior chemotherapy-containing line.

- H&N, NETs, biliary tract, CUP: one or two prior chemotherapy-containing lines

- GCTs: no limit of prior therapy

- EFTs: no more than two prior chemotherapy-containing lines in the
metastatic/recurrent setting.

- BRCA 1/2-associated metastatic breast carcinoma: at least one but no more than
three prior chemotherapy-containing lines.

- Performance status ≤ 2 [Eastern Cooperative Oncology Group (ECOG)]

- Adequate major organ function

- At least three weeks since the last chemotherapy

- Women of childbearing potential must have pregnancy excluded by appropriate testing
before study entry

Exclusion Criteria:

- Prior treatment with PM01183 or trabectedin

- Prior or concurrent malignant disease unless in complete remission for more than five
years

- Known central nervous system (CNS) involvement

- Relevant diseases or clinical situations which may increase the patient's risk

- Pregnant or breastfeeding women and fertile patients (men and women) who are not using
an effective method of contraception