Primary Outcomes:

Primary Outcome 1 - Measure: Assess the safety and tolerability of CT-0508 by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors.

Primary Outcome 1 - Time Frame: 14 months

Primary Outcome 2 - Measure: Assess the feasibility of manufacturing CT-0508 by describing the percentage of products passing release criteria.

Primary Outcome 2 - Time Frame: 12 months

Condition:

• HER2-positive
• Adenocarcinoma
• Bile Duct Cancer
• Biliary Tract Cancer
• Bladder Cancer
• Breast Cancer
• Breast Neoplasm
• Carcinoma, Ductal
• Carcinoma, Hepatocellular
• Cancer
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Ovarian Epithelial
• Carcinoma, Small Cell
• Carcinoma, Squamous
• Carcinoma, Transitional Cell
• Colorectal Cancer
• Esophagogastric Junction Neoplasms
• Inflammatory Breast Cancer
• Stomach Neoplasms
• Malignant Neoplasms
• Ovarian Neoplasms
• Pancreatic Cancer
• HER2-positive Solid Tumors
• HER2-positive Breast Cancer
• HER2-positive Gastric Cancer
• HER-2 Protein Overexpression
• HER-2 Gene Amplification

Eligibility

Criteria:
Inclusion Criteria:

- HER2-positive recurrent or metastatic solid tumors for which there are no available
curative treatment options.

- Breast cancer and gastric/gastroesophageal junction cancers must have failed
approved HER2-targeted agents.

- Other HER2-positive tumor types must have failed standard of care therapies,
while prior therapy with anti-HER2 drugs is not required.

- Subject must be willing and able to undergo tumor tissue biopsy procedures

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Subject has adequate bone marrow and organ function

Exclusion Criteria:

- HIV, active hepatitis B or hepatitis C infection.

- Diagnosis of immunodeficiency or chronic exposure to systemic corticosteroid therapy
or any other form of immunosuppressive therapy

- Untreated or symptomatic central nervous system (CNS) metastases or cytology proven
carcinomatous meningitis.

o Subjects with small, asymptomatic CNS metastases that do not require treatment are
permitted to enroll.

- Left ventricular ejection fraction (LVEF) <50% as determined by ECHO or multiple gated
acquisition scan (MUGA)

Other protocol-defined Inclusion/Exclusion may apply.

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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No