Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS

A Phase 1/2 Study of Vadastuximab Talirine (SGN-CD33A) in Combination With Azacitidine in Patients With Previously Untreated International Prognostic Scoring System (IPSS) Intermediate-2 or High Risk Myelodysplastic Syndrome (MDS)

This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS).

In the phase 1 portion of the study, escalating doses of 33A will be evaluated in combination with azacitidine, and a dose of 33A will be selected to proceed to phase 2. The phase 2 portion of the study is randomized, double-blind and placebo-controlled; it is designed to compare the overall response rate (ORR) between 2 study arms.

Inclusion Criteria:

• Subjects with cytologically/histologically confirmed MDS according to the World Health Organization (WHO) 2008 classification.
• Previously untreated for Myelodysplastic Syndrome (MDS)
• Age ≥18 years of age.
• Eligible for therapy with azacitidine.
• Life expectancy of at least 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Adequate baseline laboratory parameters.

Exclusion Criteria:

• Received prior treatment for MDS with lenalidomide or hypomethylating agents (HMAs).
• History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis.
• Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, eg, prostate or breast cancer).
• Candidates for allogeneic stem cell transplant at the time of screening.