Trial of Active Immunotherapy With OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer Subjects

Inclusion Criteria:

1. Subjects ≥21 years of age

2. Dose escalation phase: Histologically or cytologically confirmed diagnosis of gastric,
lung, colorectal or breast cancer on file Cohort expansion phase: Histologically or
cytologically confirmed diagnosis of Globo H-positive NSCLC

3. Dose escalation: Subjects with recurrent or metastatic incurable disease that failed
to respond to at least one line of anticancer standard therapy and for which standard
treatment is no longer effective or tolerable.

Cohort expansion phase: Subjects with recurrent or metastatic NSCLC who have achieved
stable disease (SD), or partial response (PR) status after at least 1 regimen of
anticancer therapy (i.e., chemotherapy, or targeted therapy, or PD-1/PD-L1 antagonists
either alone or in combination) , and there are no standard treatments available
except permitted Target or PD-1/PD-L1 therapies

4. Measurable disease (i.e., present with at least one measurable lesion per RECIST,
version 1.1.

5. Dose Escalation Phase: No known central nervous system (CNS) metastases or
neurological symptoms possibly related to active CNS metastasis in Dose Escalation
Phase.

Cohort Expansion Phase: Subjects with asymptomatic CNS metastases for at least four
weeks before study drug treatment

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 the 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.

Exclusion Criteria:

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 in Dose
Escalation Phase.

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. Dose escalation phase: 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 single prophylactic use in CT/MRI scan or other one-time
use in approved indications. The interval between IV/oral steroids administration
and first dose of OBI-833/OBI-821 must be more than pharmacological duration or 5
half-lives of administered steroids, whichever is the longer. Uses of inhaled and
topical use of steroids are allowed.

- Another investigational drug

Cohort Expansion Phase: Subjects with any of the following MEDICATIONS within 4 weeks
prior to IP treatment, except permitted therapies:

- Chemotherapeutic Agent

- Immunotherapy [Interferons, Cytokines] (except PD-1/PD-L1 antagonists)

- Immunosuppressants (e.g., cyclosporin, rapamycin, tacrolimus, rituximab,
alemtuzumab, natalizumab, etc.).

- IV/oral steroids except single prophylactic use in CT/MRI scan or other one-time
use in approved indications. The interval between IV/oral steroids administration
and first dose of OBI-833/OBI-821 must be more than pharmacological duration or 5
half-lives of administered steroids, whichever is longer. Uses of inhaled and
topical steroids are allowed.

- 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.