Metastatic Gastric, Lung, Colorectal or Breast Cancer

• To evaluate the safety and tolerability of OBI-833/OBI-821 in subjects with advanced/metastatic gastric, lung, colorectalor, breast cancer. • To assess humoral immune responses (anti-Globo H IgG and IgM production) following subcutaneous administration of OBI-833/OBI-821

OBI-833 (Globo H-CRM197)/OBI-821

Globo H-CRM197
OBI-821

Injection

125μg/vial
150μg/vial

Endpoints:
Primary: Safety and Tolerability
Secondary: Immune response (anti-Globo H IgG and IgM production)
Tumor response (per RECIST criteria)

Inclusion Criteria:
1. Subjects≧21 years of age
2. Histologically or cytologically confirmed diagnosis of gastric, lung, colorectal or breast cancer on file
3. Subjects with recurrent or metastatic incurable disease that failed to respond to at least one line of anticancer standard therapy or no further standard treatments available
4. Measurable disease (i.e., present with at least one measurable lesion per RECIST, version 1.1 [Eisenhauer 2009]).
5. No known central nervous system (CNS) metastases or neurological symptoms possibly related to active CNS metastasis.
6. Performance status: ECOG≦1
7. Organ Function Requirements – Subjects must have adequate organ functions as defined below:
- AST/ALT ≦ 3X ULN (upper limit of normal)
- AST/ALT ≦ 5X ULN [with underlying liver metastasis]
- Total bilirubin ≦ 2.0 X ULN
- Serum creatinine ≦ 1.5X ULN
- ANC ≧1500 /μL
- Platelets > 100,000/μL
8. Subjects of child-bearing potential must agree to use acceptable contraceptive methods during treatment and until the end of study. Subject not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
9. Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.

1. Patients who have not received standard chemotherapy, hormonal or targeted therapy for their underlying advanced/metastatic cancer.
2. Subjects who are pregnant or breast-feeding at entry.
3. Subjects with splenectomy.
4. Subjects with known or clinically manifest, symptomatic CNS metastases.
5. Subjects with HIV infection, active hepatitis B infection or active hepatitis C infection.
6. Subjects with any autoimmune disorders requiring iv/oral steroids or immunosuppressive or immunomodulatory therapies.
- e.g., Type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Grave’s disease, Hashimoto’s thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, etc.
7. Subjects with any known uncontrolled inter-current illness including ongoing or active infections, symptomatic congestive heart failure (NYHA>2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
8. Subjects with any of the following MEDICATIONS within 4 weeks prior to IP treatment, except permitted therapies as listed in section 7.1:
- Chemotherapeutic Agent
- Immunotherapy [mAbs, Interferons, Cytokines (except GCSF)]
- Immunosuppressants (e.g., cyclosporin, rapamycin, tacrolimus, rituximab, alemtuzumab, natalizumab, etc.).
- IV/oral steroids except inhaled or topical use
- Another investigational drug
9. Subjects with pleural effusions and/or ascites, due to malignancy, requiring paracentesis every 2 weeks or more frequently.
10. Subjects with any known severe allergies (e.g., anaphylaxis) to any active or inactive ingredients in the study drugs.