A Phase 1, Open-Label, Dose Escalation Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of SNDX-6352 Monotherapy and SNDX-6352 in Combination with Durvalumab in Patients with Unresectable, Recurrent, Locally-Advanced, or Metastatic Solid Tumors
Johns Hopkins Kimmel Cancer Center in Baltimore
To investigate safety and tolerability of SNDX-6352 to determine maximum tolerated dose and recommended Phase 2 dose in patients. To determine the pharmacokinetic profile and immunogenicity of SNDX-6352.
Patients must be 18 years or older with confirmed unresectable, recurrent, locally-advanced or metastatic solid tumors with evaluable disease and must have progressed following prior treatment and have no standard therapy options left. Good performance status as determined by study team evaluation. Adequate laboratory values as determined at screening. Side effects from prior chemotherapy treatment must have resolved. No pregnant or breast feeding females. All participants, male and female must agree to adequate birth control measures during and for a period after treatment completion. No immunosuppressive medication within 14 days before first dose. No previous treatment with a CSF-1, CSF-1R, and/or IL-34 blocking agents. No history of immune deficiencies or autoimmune disease. No TB. No uncontrolled hypertension or diabetes mellitus. No active infection requiring systemic therapy. No symptomatic brain metastases requiring steroids. No live vaccine within 30 days of 1st dose. No GCSF. Cannot have participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of study drug. No known history of human immunodeficiency virus (HIV), active hepatitis B or hepatitis C. No kidney and/or liver impairment. No known alcohol or drug abuse. No known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
SNDX-6352 is a IgG4 mAB that blocks CSF-1R. SNDX-6352 will be administered as an IV infusion over 30 minutes every 2 weeks. Patients will have to come to clinic for study blood draws at set time points per study calendar.
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