A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers

CC-90002-ST-001 is an open-label, Phase 1, dose escalation, first in human (FIH) clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with advanced, refractory solid and hematologic cancers.

The study will be conducted in two parts. Part A dose escalation phase will explore escalating dose cohorts of the study drug CC-90002.

Part B dose escalation will explore escalating doses of CC-90002 in combination with rituximab in subjects with CD20-positive NHL.

Inclusion criteria

• Men and women, 18 years or older, with advanced, relapsed or refractory solid tumors, Multiple Myeloma (MM) or non-Hodgkin's lymphoma (NHL) in Part A. In Part B, relapsed and/or refractory CD20-positive NHL subjects only.
• At least one site of measurable disease in subjects with solid tumors and NHL.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Subjects must have adequate hematopoietic, liver, renal and coagulation function as assessed by specific laboratory criteria.
• Females and males must agree to contraceptive methods and avoid conceiving throughout the study, and for up to 8 weeks following the last dose of CC-90002. If participating in Part B, females of child bearing potential should continue to use effective contraceptive methods for 12 months following treatment with rituximab

Exclusion criteria

• High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia.
• High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden.
• Symptomatic central nervous system involvement.
• Impaired cardiac function or clinically significant cardiac disease.
• Prior Red blood cell (RBC) transfusion < 3 months prior to starting CC-90002 (Part A only).
• Prior autologous stem cell transplant ≤ 3 months prior to starting CC-90002.
• Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90002.
• Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter.
• Major surgery ≤ 2 weeks prior to starting CC-90002.
• Pregnant or nursing females.
• Known HIV infection.
• Known chronic, active hepatitis B or C (HBV/HCV) infection.
• Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
• History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
• History of concurrent second cancers requiring active, ongoing systemic treatment.

concurrent second cancers requiring active, ongoing systemic treatment.