This phase I trial tests the safety and side effects of SX-682 in combination with standard of care treatment carfilzomib, daratumumab-hyaluronidase, and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). SX-682 works by blocking certain sites on cells that suppress the ability of the immune system to destroy tumor cells. Blocking those specific sites allows other cells of the immune system to become “free” to kill tumor cells. Carfilzomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and tumor cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill tumor cells, while hyaluronidase helps to deliver daratumumab to CD38-expressing tumor cells and kill them. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving SX-682 in combination with carfilzomib, daratumumab-hyaluronidase and dexamethasone may be safe and tolerable in treating patients with relapsed or refractory multiple myeloma.
Additional locations may be listed on ClinicalTrials.gov for NCT06622005.
Locations matching your search criteria
United States
New York
Buffalo
Roswell Park Cancer InstituteStatus: Active
Contact: Jens Hillengass
Phone: 716-845-8515
PRIMARY OBJECTIVE:
I. To assess the safety and tolerability of CXCR1/2 inhibitor SX-682 (SX-682) when combined with standard of care (SOC) treatment with carfilzomib, daratumumab and recombinant human hyaluronidase (daratumumab-hyaluronidase) and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM).
SECONDARY OBJECTIVE:
I. Evaluate for efficacy.
EXPLORATORY OBJECTIVES:
I. Rate of measurable or minimal residual disease (MRD) negativity at 6 months after treatment.
II. Identify the appropriate immunomodulatory dose levels of SX-682 as manifested by changes in peripheral blood and bone marrow (BM) myeloid populations and plasma biomarkers for future therapeutic phase II/III trials.
III. To assess the impact of SX-682 on the tumor microenvironment (TME).
OUTLINE:
Patients receive SX-682 orally (PO) twice daily (BID) on days 1-21 of each cycle. Patients also receive daratumumab-hyaluronidase subcutaneously (SC) once a week (QW) on cycles 1 and 2 and once every two weeks (Q2W) on cycles 3-6 and carfilzomib intravenously (IV) on days 1, 8, and 15 and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with sustained response after 6 cycles may continue to receive SX-682 PO BID on days 1-21, daratumumab-hyaluronidase SC on day 1, carfilzomib IV on days 1, 8, and 15 and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, BM aspiration, echocardiography (ECHO) and positron emission tomography (PET)/computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study.
After completion of study treatment, patients are followed up every 3 months for 3 years and then yearly for up to 10 years.
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorJens Hillengass
