RecruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests adding cirtuvivint to irinotecan chemotherapy for adults whose small cell lung cancer has worsened after platinum-based chemotherapy. It will check side effects, whether tumors shrink, and how long the cancer stays from getting worse.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • Tests of tissue or cells confirm small cell lung cancer that worsened after at least one platinum-based chemotherapy treatment, with or without immune therapy.
  • Your cancer can be measured on scans.
  • You can care for yourself and are up and moving for at least half of your waking hours.
  • Your blood cell counts, liver tests, and kidney tests meet the study’s limits.
  • Men and women who could become pregnant must agree to use birth control before and during the study and for 31 weeks after the last study treatment.
  • You or your legal representative must sign a form agreeing to join the study.

Who can't join

  • You have another cancer that could affect study safety or results, or you are taking another experimental drug.
  • You previously stopped irinotecan because of side effects, or you have allergies to drugs similar to the study drugs.
  • You have untreated brain tumors causing symptoms or bleeding in the brain. Treated brain tumors that are not growing, or tiny brain tumors under 5 mm without symptoms, may be allowed.
  • You have diarrhea needing medical treatment, serious liver disease, or eye problems involving the retina—the light-sensing layer at the back of the eye.
  • You had major surgery within 28 days before treatment, or still have moderate or worse side effects from past treatment. Some side effects are allowed.
  • You are pregnant or breastfeeding. Women who could become pregnant need a negative blood pregnancy test within 7 days before treatment.
  • You have HIV that has not been controlled with treatment for at least 6 months, hepatitis B still detectable during treatment, or hepatitis C that has not been cured or controlled during treatment.
  • You use foods or drugs that strongly affect the liver enzyme CYP3A4 within 10 days before treatment, or your heart rhythm test shows a QTc interval over 480 milliseconds. Special rules apply for pacemakers.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Study sites (1)

MO

  • Washington University School of Medicine · St Louis, MO 63110Ramaswamy Govindan, M.D. · Study contact · 314-362-5737 · rgovindan@wustl.eduRamaswamy Govindan, M.D. · Principal investigatorFeng Gao, Ph.D. · Sub-investigatorJanelle Mann, PharmD, BCOP · Sub-investigatorMore trials in St Louis