Phase 1 Dose-Escalation Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases

Inclusion Criteria

Inclusion Criteria (abbreviated):

1. Documented carcinoma refractory to standard treatment (or for whom no standard
treatment is available). Hepatocellular carcinoma (HCC) is not allowed.

2. Hepatic metastases

3. ECOG Performance Status of 0 or 1, or Karnofsky Performance Status (KPS) of 80% to
100%.

4. Adequate organ function as defined by clinical hematology and chemistry assays.

Exclusion Criteria (abbreviated):

1. Known central nervous system metastases.

2. History of allergic reactions attributed to sulfa or beta-lactam antibiotics.

3. Cardiac conditions associated with high- or moderate-risk of endocarditis.

4. Intra-arterial hepatic catheter, hepatic cirrhosis, or clinically relevant ascites.

5. Artificial (prosthetic) joint or other artificial implant or devices that cannot
easily be removed.

6. Known coagulation disorder or recent thromboembolic event.

7. Use of immunosuppressive agent, chemotherapy, or radiation therapy within 28 days
prior to CRS-100; bone marrow or stem cell transplant or a major organ allograft;
autoimmune disease.

8. Current history of gallstones or kidney stones.

9. Infection with HIV, human t-lymphotropic virus type 1 (HTLV-1), hepatitis c virus
(HCV), or hepatitis b virus (HBV).

10. Pregnant or lactating