A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma

Inclusion Criteria:

- Age between 15-80 years (US only), and 18-80 (rest of world (ROW)), male or female.

- Adjuvant or neoadjuvant chemotherapy (including doxorubicin) allowed if no tumor
recurrence for at least 12 months since the last measurement, beginning or end of
last chemotherapy.

- Histologically or cytologically confirmed, locally advanced, unresectable, and/or
metastatic soft tissue sarcoma of intermediate or high grade.

- Capable of providing informed consent and complying with trial procedures.

- ECOG performance status 0-2.

- Life expectancy > 12 weeks.

- Measurable tumor lesions according to RECIST 1.1 criteria.

- Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year,
surgically sterile, or practicing adequate birth control methods) for the duration of
the study. (Adequate contraception includes: oral contraception, implanted
contraception, intrauterine device implanted for at least 3 months, or barrier method
in conjunction with spermicide.)

- Women of child bearing potential must have a negative serum or urine pregnancy test
at the Screening Visit and be non-lactating.

- Geographic accessibility to the site that ensures the subject will be able to keep
all study-related appointments.

Exclusion Criteria:

- Prior chemotherapy unless for adjuvant or neoadjuvant therapy with no tumor
recurrence for at least 12 months.

- Prior exposure to > 3 cycles or 225 mg/m2 of doxorubicin or Doxil®.

- Palliative surgery and/or radiation treatment less than 4 weeks prior to
Randomization.

- Exposure to any investigational agent within 30 days of Randomization.

- Current Stage 1 or 2 soft tissue sarcomas.

- Current evidence/diagnosis of alveolar soft part sarcoma, chondrosarcoma,
rhabdomyosarcoma, osteosarcoma, gastrointestinal stromal tumor (GIST),
dermatofibrosarcoma, Ewing's sarcoma, Kaposi's sarcoma, mixed mesodermal tumor, clear
cell sarcomas and unresectable low grade liposarcomas.

- Central nervous system metastasis

- History of other malignancies except cured basal cell carcinoma, superficial bladder
cancer or carcinoma in situ of the cervix unless documented free of cancer for > 5
years.

- Laboratory values: Screening serum creatinine > 1.5x upper limit of normal (ULN),
alanine aminotransferase (ALT) > 3 × ULN or >5 × ULN if liver metastases are present,
total bilirubin > 3 × ULN, absolute neutrophil count < 1,500/mm3, platelet
concentration < 100,000/mm3, hematocrit level < 25% for females or < 27% for males,
or coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT],
International Normalized Ratio [INR]) > 1.5 × ULN, albumin < 2.0 g/dL.

- Clinically evident congestive heart failure > class II of the New York Heart
Association (NYHA) guidelines.

- Current, serious, clinically significant cardiac arrhythmias, defined as the
existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown
III, IV or V.

- Baseline QTc > 470 msec and/or previous history of QT prolongation while taking other
medications. Concomitant use of medications associated with a high incidence of QT
prolongation is not allowed.

- History or signs of active coronary artery disease with or without angina pectoris.

- Serious myocardial dysfunction defined as scintigraphically (e.g. MUGA, myocardial
scintigram) or ultrasound determined absolute left ventricular ejection fraction
(LVEF) < 45% of predicted.

- History of HIV infection.

- Active, clinically significant serious infection requiring treatment with
antibiotics, anti-virals or anti-fungals.

- Major surgery within 3 weeks prior to Randomization.

- Substance abuse or any condition that might interfere with the subject's
participation in the study or in the evaluation of the study results.

- Any condition that is unstable and could jeopardize the subject's participation in
the study.