Cirtuvivint + Irinotecan for Small Cell Lung Cancer

RG
Overseen ByRamaswamy Govindan, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding cirtuvivint, a new drug, to the chemotherapy drug irinotecan can help treat small cell lung cancer (SCLC) that has returned after treatment. Researchers aim for this combination to increase cancer cells' sensitivity to treatment, improving response and delaying cancer progression. Individuals treated for SCLC who have experienced a recurrence may be suitable for this study, particularly if their previous treatment ceased to be effective. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug combination.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but you cannot use drugs that strongly affect CYP3A4, like ketoconazole or rifampin, within 10 days before starting the study medication.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cirtuvivint, when combined with irinotecan, is under study for its safety and effectiveness in treating small cell lung cancer (SCLC). Cirtuvivint targets specific proteins that aid cancer cell growth. Early lab studies showed promise in stopping tumor growth and enhancing cancer cells' responsiveness to chemotherapy.

Currently, clinical trials are testing cirtuvivint to better understand its safety in humans. The early trial stages focus on patient tolerance and identifying possible side effects. Although detailed safety information is still being gathered, this phase suggests careful monitoring of safety before broader testing.

Irinotecan, the other drug in this combination, is already used in cancer treatments and has known side effects, which doctors are experienced in managing. The combination with cirtuvivint is under study to determine if it remains safe and enhances treatment effectiveness. While the complete safety picture is still developing, the trial phase indicates a careful approach to understanding any risks involved.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Cirtuvivint combined with Irinotecan for treating small cell lung cancer because this combination targets the cancer in a unique way. Unlike traditional treatments like chemotherapy, which broadly attacks rapidly dividing cells, Cirtuvivint is a novel agent that specifically disrupts the Wnt signaling pathway, a crucial process that many cancer cells rely on to grow. By combining this with Irinotecan, a well-established chemotherapy drug, the treatment aims to enhance cancer cell death while potentially reducing damage to normal cells. This targeted approach could lead to more effective and less toxic treatment options for patients.

What evidence suggests that this trial's treatments could be effective for small cell lung cancer?

This trial will evaluate the combination of cirtuvivint and irinotecan for treating small cell lung cancer (SCLC) that has returned after initial treatment. Research has shown that this combination targets specific proteins that aid cancer cell growth. Lab studies demonstrated that blocking these proteins halted tumor growth and increased cancer cells' responsiveness to chemotherapy. Although human studies remain limited, early results for this combination are promising in improving treatment response and slowing disease progression. Participants in this trial will receive both cirtuvivint and irinotecan as part of the study treatment.12345

Who Is on the Research Team?

RG

Ramaswamy Govindan, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

The SLICK Trial is for individuals with relapsed Small Cell Lung Cancer (SCLC) who have previously undergone treatment. The trial aims to test a new combination of drugs in patients whose cancer has returned after initial therapy.

Inclusion Criteria

Presence of measurable disease per RECIST 1.1 criteria
Adequate bone marrow and organ function: Absolute neutrophil count ≥ 1.0 K/cumm, Platelets ≥ 100 K/cumm, Total bilirubin ≤ 1.5 x IULN, 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
Ability to understand and willingness to sign an IRB approved written informed consent document
See 4 more

Exclusion Criteria

Previous intolerance to irinotecan, unless treatment was not discontinued for treatment-related adverse events
Currently receiving any other investigational agents
Pregnant and/or breastfeeding
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Cirtuvivint is administered orally on a 5 days on/2 days off schedule at the starting dose level, and on a 2 days/week schedule at other dose levels. Irinotecan is given on Days 1 and 8 of a 21-day cycle.

21 days per cycle

Phase II Treatment

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.

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cirtuvivint
  • Irinotecan
Trial Overview This study examines the effectiveness and safety of combining Cirtuvivint, a molecule that inhibits certain kinases involved in tumor growth, with Irinotecan, a chemotherapy drug, to see if this duo can improve outcomes for SCLC patients.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Phase II: Irinotecan + CirtuvivintExperimental Treatment2 Interventions
Group II: Phase I: Irinotecan + CirtuvivintExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Biosplice Therapeutics, Inc.

Industry Sponsor

Trials
22
Recruited
5,300+

Citations

Small Cell Lung Cancer Irinotecan and CDC2-like Kinase ...This study is testing the hypothesis that adding cirtuvivint to chemotherapy in patients with relapsed SCLC will be well tolerated and improve ...
Cirtuvivint + Irinotecan for Small Cell Lung CancerSubsequent 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 ...
Cirtuvivint: A New Investigational Drug for Cancer TreatmentBased on the clinical trials data, Cirtuvivint is currently being tested for several types of cancer, including: soft tissue sarcomas, small cell lung cancer, ...
Biosplice Therapeutics Announces First Patient Dosed in ...The trial (NCT06484062) is evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of cirtuvivint, both as a ...
Small Cell Lung Cancer Irinotecan and CDC2-like Kinase ...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 ...
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