NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer

Up to 20 patients will be treated at each dose in Part I of the study. In Part II of the
study, one of the treatment dose levels will be selected for further evaluation. The dose
selection will be based on clinical and laboratory assessments of patients recruited in Part
I. Patients will only participate in either Part I or II. A total of 64 patients will be
treated in Part I and Part II combined.

Eligible consenting patients will receive NUC-1031 by IV infusion on days 1, 8 and 15 of each
28-day cycle. Patients will continue to receive NUC-1031 until the occurrence of disease
progression. Patients will undergo imaging every 8 weeks. After disease progression, patients
will be followed for overall survival.

Inclusion Criteria:

1. Provision of signed written informed consent.

2. Original diagnosis and/or histological confirmation of high-grade serous, high-grade
endometrioid, undifferentiated/unclassifiable epithelial ovarian, fallopian tube or
primary peritoneal cancer.

3. Time from the last line of platinum-based chemotherapy of less than 6 months.

4. Received at least 3 prior chemotherapy-containing regimens.

5. Age ≥18 years.

6. Ability to comply with protocol requirements.

7. Patients are not of childbearing potential or they must agree to use a physical method
of contraception.

Exclusion Criteria:

1. Disease that progressed while receiving initial line of platinum-based chemotherapy.

2. Received fewer than 3 prior chemotherapy-containing regimens.

3. Prior therapy with single-agent gemcitabine.

4. Prior history of hypersensitivity to gemcitabine.

5. Prior chemotherapy, radiation (other than short cycle of radiation to reduce bone
pain), treatment with a VEGF inhibitor, PARP inhibitor or immunotherapy within 21 days
of first receipt of study drug. Hormone therapy within 14 days of first receipt of
study drug.

6. Residual side effects from chemotherapy or radiation, which have not gotten better
except for nerve pain or tingling or hair loss.

7. Patients who have a history of another type of cancer diagnosed within the past 5
years, with the exception of adequately treated non-melanoma skin cancer curatively
treated cervical cancer or ductal carcinoma in situ (DCIS) of the breast.

8. Presence of an serious illness, uncontrolled illness, or active infection requiring IV
antibiotics.

9. Presence of any serious illnesses, serious medical conditions, serious medical
history, active bacterial or viral infections including hepatitis B or C, or known to
be HIV positive.

10. Currently pregnant, lactating or breastfeeding.

11. History of blocked intestines because of ovarian cancer, unless fully resolved.