Q702 for the Treatment of Patients With Hematologic Malignancies

Description

PRIMARY OBJECTIVES:

I. Establish the highest dose of Q702 tested that has acceptable tolerability and safety. (Dose determination) II. Safety and overall response assessment in patients with hematologic malignancies who have been treated with Q702. (Dose expansion)

SECONDARY OBJECTIVES:

I. Assessment of progression-free survival and overall survival. II. Safety and tolerability of Q702.

EXPLORATORY OBJECTIVE:

I. Improvement of quality of life (QOL) assessed by using the Patient-Reported Outcomes Measurement Information System (PROMIS) tool compared to pretreatment values.

CORRELATIVE OBJECTIVES:

I. Programmed Death-Ligand 1 (PD-L1), Colony stimulating factor 1 receptor (CSF1R) expression of tumor before and after treatment.

II. M2 macrophage population assessed through flow cytometry by using peripheral blood before and after treatment.

III. Serum cytokine interferon gamma, Interleukin (IL)-1b, IL-6, IL-4, IL-10, IL-13, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) before and after each cycle of therapy.

IV. Assessment of inflammatory markers before and after treatment with Q702. V. Assessment of cluster of differentiation 4 (CD4)/cluster of differentiation 8 (CD8) infiltration in the tumor involvement before, during, and after treatment with Q702.

OUTLINE: This is a dose-escalation study of Q702 followed by a dose-expansion study.

Patients receive Q702 orally (PO) daily (QD) on days 1-7 and 15-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients who have not progressed/relapsed may continue on therapy at their current dose at medical doctor (MD)/patient discretion for an additional 6 cycles. Patients undergo blood and urine sample collection and may undergo positron emission tomography (PET) scan/computed tomography (CT) scan or magnetic resonance imaging (MRI) and bone marrow aspiration and biopsy throughout the study.

After completion of study treatment, patients are followed up every 6 months and at progressive disease for 2 years.