Actively Recruiting
Phase I Study of Q702, a CSF1R and TAM Receptor Inhibitor, in Patients With Hematologic Malignancies
Led by Mayo Clinic · Updated on 2025-10-10
46
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Q702, an immunomodulatory drug, in a phase I clinical trial for patients with various hematologic malignancies, including relapsed or refractory lymphomas and histiocytic disorders. The study aims to find the best safe dose of Q702, assess its safety and side effects, and explore its impact on patients' quality of life and tumor markers. This research is sponsored by Mayo Clinic and focuses on improving treatment options for patients who have limited or failed previous therapies. Participants receive Q702 by mouth daily on days 1-7 and 15-21 of each 28-day cycle. After six cycles, those who have not experienced disease progression may continue treatment for up to six additional cycles based on medical and patient choice. Throughout the study, patients undergo blood and urine tests, imaging scans like PET, CT, or MRI, and bone marrow biopsies to monitor disease and treatment effects. The trial includes a dose-escalation phase followed by an expansion phase to assess overall response. During participation, patients are regularly evaluated with laboratory tests and imaging to track disease status and safety. Quality of life is assessed using patient-reported questionnaires. After completing treatment, participants are followed every six months for two years to monitor long-term outcomes. The main study measures include dose-related toxicities and overall response rate, as well as progression-free and overall survival over up to three years.
CONDITIONS
Brief Title
Q702 for the Treatment of Patients With Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with specified hematologic malignancies including relapsed/refractory histiocytic diseases, lymphomas, or myelodysplastic syndromes
- Not eligible for or have failed established therapies
- Ability to swallow oral medication
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Life expectancy of at least 3 months
- Measurable or assessable disease as defined by imaging or biopsy
- Adequate blood counts and organ function within 14 days prior to registration
- Willingness to provide blood, bone marrow, saliva, and tissue samples for research
- Use of effective contraception for sexually active participants and partners
- Ability to complete questionnaires independently or with assistance
- Willing to return for follow-up visits
You will not qualify if you...
- Active central nervous system metastases or carcinomatous meningitis in myeloproliferative neoplasm patients
- Pregnant or nursing persons, or those unwilling to use adequate contraception
- Severe cardiac disease or recent serious cardiac events
- Corrected QT interval greater than 470 msec
- Active infections with HIV, HTLV-1, hepatitis B or C, unless controlled as specified
- Active uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
- Use of strong CYP enzyme inhibitors or inducers or herbal supplements as specified
- Recent treatment with targeted therapies, monoclonal antibodies, chemotherapy, surgery, investigational therapies, or radiation within defined washout periods
- Failure to recover from acute effects of prior therapies
- Severe concurrent illnesses interfering with study participation
- Active retinal disorders posing risk for drug-induced retinopathy
- Active second malignancy requiring treatment that would interfere with study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles of 28 days each
Participants receive Q702 orally daily on days 1-7 and 15-21 of each 28-day cycle. Treatment continues in the absence of disease progression or unacceptable toxicity. After 6 cycles, participants who have not progressed may continue therapy for up to an additional 6 cycles at the discretion of the medical doctor and participant. Throughout treatment, participants undergo blood and urine sample collection and may have PET, CT, or MRI scans as well as bone marrow aspiration and biopsy.
Repeated visits every cycle with sample collections and imaging as scheduled by the study
Duration - Up to 2 years
After completing treatment, participants are followed up every 6 months and at progressive disease for 2 years to monitor health status and survival.
Visits every 6 months and as needed at progression
Trial Site Locations
Total: 2 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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