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SLICK Trial: Cirtuvivint and Irinotecan for Small Cell Lung Cancer

This study is testing a new combination treatment for small cell lung cancer (SCLC) that has progressed after initial platinum-based chemotherapy. Researchers are investigating if adding Cirtuvivint to Irinotecan can improve outcomes. Cirtuvivint is a drug that works by blocking certain proteins (CDC2-like kinases and dual-specificity tyrosine-regulated kinases) that may help cancer cells grow and become resistant to chemotherapy. The study aims to find the best dose of Cirtuvivint to use with Irinotecan and to see how many patients respond to this treatment. You may be able to join if you are at least 18 years old and have SCLC that has progressed after at least one line of platinum-based chemotherapy.

Study design
This is an interventional study with a planned enrollment of 42 participants. It will determine the recommended dose in Phase I and then measure objective response rate in Phase II.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured through completion of cycle 1 (21 days) for Phase I patients, and through completion of treatment (estimated to be 4 months) for Phase II patients.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07155200

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Washington University School of Medicine
~42 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:CirtuvivintIrinotecan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended Phase II dose (RP2D) (Phase I only)
Measured over Through completion of cycle 1 (cycle is 21 days) for all Phase I patients
+1 more outcome measured

Conditions

Small-cell Lung Cancer
Small Cell Lung Carcinoma
Small Cell Lung Cancer

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Lung Small Cell Carcinoma

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Ramaswamy Govindan, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Ramaswamy Govindan, M.D.
[email protected]
314-362-5737
Email the study team

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed small cell lung cancer that has progressed on at least one line of prior platinum-based chemotherapy, given with or without anti-PD-(L)1 therapy.
Presence of measurable disease per RECIST 1.1 criteria
At least 18 years of age.
ECOG performance status ≤ 2
Adequate bone marrow and organ function as defined below:
Absolute neutrophil count ≥ 1.0 K/cumm
Platelets ≥ 100 K/cumm
Total bilirubin ≤ 1.5 x IULN (except participants with Gilbert's syndrome, who must have total bilirubin \< 3.0 mg/dL)
AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN (≤ 5 x IULN for patients with liver metastases)
Calculated creatinine clearance \> 35 mL/min by Cockcroft-Gault
The effects of cirtuvivint on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 31 weeks after completion of study treatment (either drug). Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform the treating physician immediately.
Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion

Prior or concurrent malignancy whose treatment or natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition (following discussion with the PI) are eligible for this trial.
Previous intolerance to irinotecan. Treatment with prior irinotecan is allowed as along as treatment was not discontinued for treatment related adverse events.
Currently receiving any other investigational agents.
Patients with untreated symptomatic brain metastases or with clinically evident CNS hemorrhage. Patients with treated brain metastases are allowed if post-treatment brain imaging after CNS-directed therapy shows no evidence of progression. Patients with asymptomatic, punctate brain metastases \< 5 mm are allowed.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to cirtuvivint, irinotecan, or other agents used in the study.
Concurrent diarrheal illness (such as inflammatory bowel disease) that requires medical therapy.
Undergone major surgery within 28 days prior to Cycle 1 Day 1
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis at a level of Child-Pugh B or worse, cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis (defined as ascites from cirrhosis requiring diuretics or paracentesis), fatty liver, and inherited liver disease.
Unresolved grade 2 or higher toxicities from previous treatment with the exception of fatigue, lymphopenia, anemia, endocrine AEs that are being managed with hormone replacement, alopecia, or dysgeusia.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to C1D1.
HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing is not required in the absence of known history of infection.
Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing is not required in the absence of known history of infection.
History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing is not required in the absence of known history of infection.
Known retinal abnormalities, including diabetic retinopathy, macular degeneration, other retinal degenerative diseases, or other retinal findings that may place the patient at risk.
Patients currently using or anticipating the need for food or drugs known to strongly inhibit or induce CYP3A4, such as ketoconazole, itraconazole, erythromycin, or rifampin, within 10 days prior to first dose of study medication.
Patients with a corrected QT interval (QTc) using Fridericia's formula (QTcF) \> CTCAE v5.0 Grade 1 (\>480 msec) based on the mean of triplicate evaluation at Screening. In patients with ventricular paced rhythm, a 50 msec subtraction should be applied to the QTc to calculate the QTcF, potential exceptions for patients with pacemakers should be discussed with the PI.

What this trial measures

  • Recommended Phase II dose (RP2D) (Phase I only)Through completion of cycle 1 (cycle is 21 days) for all Phase I patients

    \- The RP2D is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. Dose-limiting toxicities are defined in the protocol.

  • Objective response rate (ORR) per RECIST criteria (Phase II and RP2D only)Through completion of treatment (estimated to be 4 months)

    * ORR: Percentage of patients who have a complete response (CR) or partial response (PR). * Complete Response (CR): Disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). * Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.