Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors

A Phase 2, Open-Label, Pharmacodynamic Study to Evaluate the Effect of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Subjects With Solid Tumors

What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by dosing with sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has determined that all of these goals could be obtained by an intense 10-patient sotatercept (ACE-011) pharmacodynamic study, completed by two well-known experts in the red cell production field.

Inclusion Criteria:

• Men and women ≥18 years of age.
• Histologically confirmed diagnosis of a solid tumor malignancy documented by cytology or biopsy.
• Presence of metastatic disease.
• Hemoglobin value between ≥8.0 to <11.0 g/dL (≥80 to <110 g/L).
• ≥28 days must have elapsed (prior to pre-dose red blood cell mass / plasma volume test) since previous treatment with erythropoiesis-stimulating agent (including concurrent treatment with intravenous [IV] iron).
• ≥28 days must have elapsed (prior to Day 1) since the last red blood cell transfusion and receipt of ≤2 units of blood in the past 56 days (prior to Day 1).
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 1.

Exclusion Criteria:

At the time of screening, participants who have any grade ≥3 toxicity (according to the currently active minor version of NCI CTCAE v4.0) except for the following disease-related toxicities:

• Hematological events - anemia, thrombocytopenia, neutropenia
• Non-hematological events - nausea, vomiting, fatigue, muscle or bone/joint pain