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RecruitingNCT06712810

Q702 for the Treatment of Patients With Hematologic Malignancies

MC220806: Phase I Study Evaluating the Efficacy of CSF1R and TAM Receptor or Inhibition in Hematologic Malignancies With Q702, a Small Molecular Inhibitor

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
46 (estimated)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGAxl/Mer/CSF1R Inhibitor Q702Given PO
PROCEDUREBiospecimen CollectionUndergo blood and urine sample collection
PROCEDUREBone Marrow AspirationUndergo bone marrow biopsy and aspiration
PROCEDUREBone Marrow BiopsyUndergo bone marrow biopsy and aspiration
PROCEDUREComputed TomographyUndergo CT scan
PROCEDUREMagnetic Resonance ImagingUndergo MRI
PROCEDUREPositron Emission TomographyUndergo PET scan
OTHERSurvey AdministrationAncillary study

Timeline

Start date
2025-08-27
Primary completion
2030-09-15
Completion
2030-09-15
First posted
2024-12-02
Last updated
2025-10-10

Locations

2 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06712810. Inclusion in this directory is not an endorsement.