A Phase 1 Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Lipotecan® (TLC388 HCl for Injection) When Administered to Patients With Advanced Solid Tumors

Inclusion Criteria:

- Adult patients defined by age ≥18 years.

- Pathologically confirmed advanced solid tumors for which standard therapy proven to
provide clinical benefit does not exist or is no longer effective

- Evaluable disease, either measurable on imaging or with informative tumor marker(s),
by RECIST (Response Evaluation Criteria in Solid Tumors) criteria.

Exclusion Criteria:

- Pregnancy or lactation. Women of childbearing potential must have a negative
pregnancy test within 7 days prior to enrolment. Male and female patients of
childbearing potential must agree to use appropriate birth control (barrier methods
with spermicides, oral or parenteral contraceptives and/or intrauterine devices)
during the entire duration of the study, or the patient must be surgically sterile
(with documentation in the patient's medical records).

- Previous malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ
of the uterine cervix, unless the tumor was treated with curative intent more than 2
years prior to study entry.

- Receipt of more than 3 prior regimens of chemotherapy.

- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
prior to baseline. Receipt of radiotherapy to >25 % of bone marrow. Major surgery
within 4 weeks prior to baseline.

- Concomitant treatment with, or anticipated use of, pharmaceutical or herbal agents
which are potent inhibitors or inducers of cytochrome P450 enzymes unless approved by
the Sponsor.

- Uncontrolled intercurrent illness that would jeopardize patient safety, interfere
with the objectives of the protocol, or limit patient compliance with study
requirements, as determined by the Investigator.