A First in Human Study of AUR 103 Calcium to Evaluate Safety, Pharmacokinetics and Pharmacodynamics

Required: CD20 overexpression (CD20+)

Patients of CD20+ B cell NHL

Must have received: cytotoxic chemotherapy — metastatic (solid tumor), relapsed/refractory (hematologic)

patients should have received at least 2 lines of therapy in the metastatic setting (solid tumor); relapsed / refractory AML (patients should have received at least one line of previous therapy); NHL: at least two lines of therapy previously

Must have received: CD20 antibody (rituximab) — NHL

Patient must have received treatment with chemotherapy and CD20 antibody previously ... and be eligible to receive Rituximab

Must have received: BTK inhibitor — Marginal Zone Lymphoma, Mantle Cell Lymphoma

Patient must have received BTK inhibitors and PI3K inhibitors, unless not available locally to the patient

Must have received: PI3K inhibitor — Marginal Zone Lymphoma

Patient must have received BTK inhibitors and PI3K inhibitors, unless not available locally to the patient

Must have received: antibiotic therapy — Extra nodal Marginal Zone Lymphoma of MALT tissue

Patient must have received treatment with accepted antibiotic therapy for H. Pylori as well as chemotherapy and CD20 antibody previously

Must have received: high dose chemotherapy with autologous stem cell transplant — DLBCL, High-grade B cell lymphomas, Mantle Cell Lymphoma

Patient must have received High Dose Chemotherapy with Autologous Stem Cell Transplant, unless patient is not eligible or has refused transplant previously

Must have received: BTK inhibitor — Mantle Cell Lymphoma

Patient must have received BTK inhibitors unless not available locally to the patient

Must have received: R-CHOP or R-CVP — DLBCL, High-grade B cell lymphomas

Patient must have received treatment with R-CHOP / R-CVP (if not eligible for doxorubicin)

Must have received: azacitidine (azacitidine) — AML, MDS

be eligible to receive Azacitidine

Cannot have received: systemic anti-cancer therapy

Exception: prednisone or medroxyprogesterone allowed; ongoing LHRH analogues for CRPC allowed in Part 1

Systemic anti-cancer therapy, such as chemotherapy, or biological therapy, immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is shorter, from the Cycle 1 Day 1 of the study. Concomitant use of prednisone or medroxyprogesterone is allowed. In Part 1, Patients with CRPC (castrate resistant prostate cancer) should continue to receive ongoing medical castration with LHRH analogues, and such patients are allowed.

Cannot have received: investigational agent

Use of any investigational agent within 28 days or 5 half-lives (whichever is shorter) prior to Cycle 1 Day 1

Cannot have received: definitive radiotherapy

Exception: limited field palliative radiation is allowed

Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial)