Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors

This study is a Phase 2 with safety lead-in study to assess the safety and efficacy of
DPX-Survivac, low dose cyclophosphamide, and pembrolizumab combination therapy in subjects
with selected advanced and recurrent solid tumours. Two ovarian cancer arms will be recruited
and randomized in this study, one with and one without cyclophosphamide. All other cohorts
will be single arm, receiving treatment with the triple combination.

Up to 20 subjects, from any cohort, will be enrolled to assess the safety of study treatments
before the study moves to the expansion phase. Once the safety lead-in is completed, the five
cohorts will be expanded to recruit additional subjects following a Simon two stage design.
Enrollment in the ovarian cancer cohort will be randomized 1:1 into two arms.

Key Inclusion Criteria:

- Subjects with advanced or metastatic solid tumours who have disease progression

1. Epithelial ovarian, fallopian tube, or peritoneal cancer

2. Hepatocellular carcinoma

3. Non-small cell lung cancer

4. Urothelial cancer

5. Microsatellite instability high solid tumours, other than the above indications

- Radiologic and/or biochemical evidence of disease progression

- Completion of pre-treatment tumour biopsy

- Subjects with HCC, NSCLC, BlCa, or MSI-H subjects other than those with gastric or
colorectal cancer must have evidence of survivin expression in their pre-treatment
biopsy sample

- Must have measurable disease by RECIST v1.1

- Ambulatory with an ECOG 0-1

- Life expectancy ≥ 6 months

- Meet protocol-specified laboratory requirements

Key Exclusion Criteria:

- Eligible for otherwise curative treatment or undergoing concurrent therapy

- Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent
directed to another stimulatory or co-inhibitory T cell receptor where subject was
discontinued from that treatment due to a Grade 3 or higher immune-related toxicity

- Prior receipt of survivin-based vaccine(s) and/or immunotherapies

- Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma
in situ, or controlled bladder cancer

- Clinical ascites or metastatic pleural fluid

- Malignant bowel obstruction or recent history of bowel obstruction

- For OvCa, subjects with any single lesion greater than 5 cm

- Autoimmune disease requiring treatment within the last two years (except replacement
therapy)

- Recent history of thyroiditis

- Any history of (non-infectious) pneumonitis that required steroid therapy or current
pneumonitis

- Presence of a serious acute or chronic infection

- Active CNS metastases and/or carcinomatous meningitis

- GI condition that might limit absorption of oral agents

- Allogenic tissue/solid organ transplant

- Other serious intercurrent chronic or acute illness, including myocardial infarction
or cerebrovascular event within 6 months

- Ongoing treatment with steroid therapy or other immunosuppressive

- Receipt of live attenuated vaccines

- Acute or chronic skin and/or microvascular disorders

- Edema or lymphedema in the lower limbs > grade 2

- Severe hypersensitivity (≥ Grade 3) to pembrolizumab