Synovate Study for Synovial Sarcoma, Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma

The Synovate Study is a global, randomized, double-blind, placebo-controlled, phase 3 study
in patients with unresectable, locally-advanced or metastatic NY-ESO-1 positive synovial
sarcoma following first-line systemic anti-cancer therapy.

Selected Inclusion Criteria:

- Histological diagnosis of synovial sarcoma

- Immunohistochemistry (IHC) results from tumor biopsy for NY-ESO-1 positive

- Subjects have received at least 4 but no more than 8 cycles of first-line
anthracycline or ifosfamide containing systemic anti-cancer therapy regimen

- Must have documentation of no evidence of disease progression of the tumor during or
after completion of first line systemic anti-cancer therapy

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

- Age >/= 12 years

- Life expectancy of at least 6 months

Selected Exclusion Criteria:

- Have received last dose of first-line systemic anti-cancer therapy or date of most
recent local regional therapy >28 days prior to day 1

- Have received prior NY-ESO-1 therapy

- Have received first-line systemic anti-cancer therapy with an agent other than
anthracycline or ifosfamide

- Have received treatment with systemic immunomodulatory agents within 28 days prior to
administration of the first dose of CMB305, or 5 half-lives of the drug, whichever
occurs sooner.

- Have significant immunosuppression from concurrent, recent, or anticipated need for
chronic treatment with systemic immunosuppressive dose of corticosteroids or
immunosuppressive medications.

- Have psychiatric or other medical illness, or any other condition that in the opinion
of the investigator prevents compliance with the study procedures or ability to
provide valid informed consent.

- Have history of uncontrolled autoimmune disease.

- Have a significant electrocardiogram finding or cardiovascular disease

- have inadequate organ function per protocol

- History of other cancer within 3 years

- Evidence of active tuberculosis or recent clinically-significant infection requiring
systemic therapy.

- Evidence of active HepB, HepC, or HIV infection

- Have a history of brain metastasis

- Have received cancer therapies including chemotherapy, radiation, biologic, or kinase
inhibitors, G-CSF, or GM-CSF within 3 weeks prior ot the first scheduled dose of
CMB305

- Female of child bearing potential who is pregnant, is planning to become pregnant, or
is breast feeding; or male who is sexually active with a female of child bearing
potential who is planning to become pregnant.