Actively Recruiting
Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)
Led by Washington University School of Medicine · Updated on 2025-12-22
42
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
B
Biosplice Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Although small cell lung cancer (SCLC) responds dramatically to initial platinum-based chemotherapy, recurrences are nearly universal. The addition of atezolizumab, an immune checkpoint inhibitor, to front-line chemotherapy has recently demonstrated an improvement in overall survival (OS) in extensive stage SCLC (ES-SCLC). Subsequent lines of therapies are associated with modest efficacy in patients with relapsed disease, and the median overall survival is still 12 to 13 months at best. Cirtuvivint is a small molecule inhibitor of the CDC2-like kinases (CLKs) and dual-specificity tyrosine-regulated kinases (DYRKs); inhibiting CLKs and DYRKs has been shown in preclinical models to cause tumor growth inhibition and sensitize cancer cells to cytotoxic chemotherapy. This study is testing the hypothesis that adding cirtuvivint to chemotherapy in patients with relapsed SCLC will be well tolerated and improve the response rate and progression-free survival (PFS).
CONDITIONS
Official Title
Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed small cell lung cancer that progressed after at least one prior platinum-based chemotherapy, with or without anti-PD-(L)1 therapy
- Measurable disease based on RECIST 1.1 criteria
- At least 18 years old
- ECOG performance status of 0, 1, or 2
- Adequate bone marrow and organ function, including: absolute neutrophil count ≥ 1.0 K/cumm; platelets ≥ 100 K/cumm; total bilirubin ≤ 1.5 times upper limit of normal; AST/ALT ≤ 2.5 times upper limit of normal (≤ 5 times if liver metastases present); creatinine clearance > 35 mL/min
- Agreement to use effective contraception prior to enrollment, during the study, and for 31 weeks after treatment completion if of childbearing potential
- Ability to understand and sign informed consent or have a legally authorized representative do so
You will not qualify if you...
- Prior or current malignancy that may interfere with treatment safety or assessment, unless approved after discussion
- Previous intolerance to irinotecan leading to treatment discontinuation
- Use of other investigational agents currently
- Untreated symptomatic brain metastases or active CNS hemorrhage; treated brain metastases allowed if stable; small asymptomatic brain lesions (<5 mm) allowed
- Allergic reactions to cirtuvivint, irinotecan, or similar agents
- Active diarrheal illness requiring treatment
- Major surgery within 28 days before first treatment cycle
- Significant liver disease including active hepatitis, cirrhosis with complications, fatty liver, or inherited liver disorders
- Unresolved grade 2 or higher toxicities from prior treatments except fatigue, lymphopenia, manageable endocrine effects, hair loss, or taste changes
- Pregnant or breastfeeding; women of childbearing potential must have negative pregnancy test within 7 days before treatment
- HIV infection without effective antiretroviral therapy and undetectable viral load for 6 months
- Detectable chronic hepatitis B virus on suppressive therapy; testing not required without history
- Untreated or active hepatitis C virus infection; treated and cured patients or those on treatment with undetectable viral load are eligible
- Known retinal diseases that increase risk
- Use or planned use of strong CYP3A4 inhibitors or inducers within 10 days before first dose
- Corrected QT interval >480 msec at screening (with adjustments for pacemaker patients)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
R
Ramaswamy Govindan, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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