Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)
NCT07155200 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2025-12-22
Summary
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
- Small-cell Lung Cancer
- Small Cell Lung Carcinoma
- Small Cell Lung Cancer
Interventions
- DRUG
-
Cirtuvivint
Cirtuvivint will be supplied by Biosplice.
- DRUG
-
Irinotecan is commercially available.
Sponsors & Collaborators
-
Biosplice Therapeutics, Inc.
collaborator INDUSTRY -
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Ramaswamy Govindan, M.D. · Washington University School of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-18
- Primary Completion
- 2028-07-31
- Completion
- 2029-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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