MC220806: Phase I Study Evaluating the Efficacy of CSF1R and TAM Receptor or Inhibition in Hematologic Malignancies With Q702, a Small Molecular Inhibitor
Mayo Clinic
Summary
This phase I trial tests the safety, side effects, and best dose of Q702 in treating patients with hematologic malignancies. Q702 is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving Q702 may be safe, tolerable and/or effective in treating 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 OBJ…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * PRE-REGISTRATION: Age ≥ 18 years * PRE-REGISTRATION: Not eligible for or have failed therapies with established benefits, at the discretion of the treating physician * PRE-REGISTRATION: Patients must meet one of the following criteria: * Relapsed/refractory patients with Erdheim-Chester disease, Langerhans histiocytosis, histiocytic sarcoma, or other malignant histiocytosis without activating alterations in v-Raf murine sarcoma viral oncogene homolog B (BRAF) or Mitogen-activated protein kinase kinase (MAP2K) oncogenes who have progressed after first line of therapy.…
Interventions
- DrugAxl/Mer/CSF1R Inhibitor Q702
Given PO
- ProcedureBiospecimen Collection
Undergo blood and urine sample collection
- ProcedureBone Marrow Aspiration
Undergo bone marrow biopsy and aspiration
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy and aspiration
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedurePositron Emission Tomography
Locations (2)
- Mayo Clinic in ArizonaScottsdale, Arizona
- Mayo Clinic in RochesterRochester, Minnesota