Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07155200
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cirtuvivint — DRUG
    Cirtuvivint will be supplied by Biosplice.
  • Irinotecan — DRUG
    Irinotecan is commercially available.

Study Details

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).

Key Dates

Start date
Dec 18, 2025
Status verified
Dec 2025
Primary completion
Jul 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: Irinotecan + Cirtuvivint
    At the starting dose level, cirtuvivint is administered orally on a 5 days on/2 days off schedule. At all other dose levels (both escalated and de-escalated), cirtuvivint is administered orally on a 2 days/week schedule. Irinotecan is given on Days 1 and 8 of a 21-day cycle at all dose levels
  • Experimental: Phase II: Irinotecan + Cirtuvivint
    Cirtuvivint is administered orally per the dose and schedule determined in Phase I. Irinotecan is given on Days 1 and 8 of a 21-day cycle.

Primary Outcome Measure

Recommended Phase II dose (RP2D) (Phase I only) [ Time Frame: Through completion of cycle 1 (cycle is 21 days) for all Phase I patients ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Ramaswamy Govindan, M.D.
[email protected]
314-362-5737
Ramaswamy Govindan, M.D. (PRINCIPAL_INVESTIGATOR)
Feng Gao, Ph.D. (SUB_INVESTIGATOR)
Danielle Turlington, PharmD (SUB_INVESTIGATOR)
Susrutha Puthanmadhom Narayanan, MBBS (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Washington University School of Medicine· St Louis, MO

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