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New treatment option for Small Cell Lung Cancer
Official title Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06922539
What this study is testing
What is Fenretinide?
Fenretinide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell lung cancer.
Also referred to as ST-001.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study evaluates a fenretinide phospholipid suspension for the treatment of small cell lung cancer (SCLC).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Small cell lung cancer (SCLC).
- Patients must all have at least one measurable disease site using RECIST version 1.1 criteria.
- Patients must have relapsed or refractory disease to prior treatment with platinum-based chemotherapy ± immunotherapy. There is no limit on the...
- Relapsed/refractory disease of any stage if incurable in nature, is eligible for enrollment.
- Minimum of 3 weeks or 5 half-lives, whichever is shorter must have elapsed since last systemic treatment. A 1-week washout is required for palliative...
You likely can't join if
- Mixed SCLC/NSCLC tumors are not eligible. Pregnant or breastfeeding women cannot take part in this study. Patients who have had chemotherapy or...
- Patients who are receiving any other investigational agents. SCLC patients with history of CNS metastasis may be included if CNS disease is...
- History of allergic reactions or sensitivity to retinoids or to any excipients of ST-001.
- Patients who require concurrent treatment with drugs that are strong CYP3A inducers are excluded from the trial.
- Patients who require concurrent treatment with drugs that are strong to moderate CYP3A inhibitors are excluded from the trial.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY heart...
See the full eligibility criteria
- Small cell lung cancer (SCLC).
- Patients must all have at least one measurable disease site using RECIST version 1.1 criteria.
- Patients must have relapsed or refractory disease to prior treatment with platinum-based chemotherapy ± immunotherapy. There is no limit on the number of prior systemic treatment regimens.
- Relapsed/refractory disease of any stage if incurable in nature, is eligible for enrollment.
- Minimum of 3 weeks or 5 half-lives, whichever is shorter must have elapsed since last systemic treatment. A 1-week washout is required for palliative radiation treatment and 2-week washout is required for whole brain...
- ECOG performance status 0-1 (Karnofsky ≥60%).
- Life expectancy greater than 6 months.
- Patients must have normal organ and marrow function.
- Triglyceride blood level (fasting) \<300mg/dL at time of enrollment (normal: \<150mg/dL; borderline high = 150-199mg/dL; high = 200-499mg/dL; very high = 500mg/dL or higher).
- Women of non-child bearing potential, that is women who have been menopausal or surgically sterile for more than 1 year, are eligible for enrolment in the study.
- Informed consent of the patient or a legal authorized representative (LAR) must be obtained prior to any study related procedures.
- Mixed SCLC/NSCLC tumors are not eligible. Pregnant or breastfeeding women cannot take part in this study. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior...
- Patients who are receiving any other investigational agents. SCLC patients with history of CNS metastasis may be included if CNS disease is asymptomatic and controlled without progression at least 4 weeks after...
- History of allergic reactions or sensitivity to retinoids or to any excipients of ST-001.
- Patients who require concurrent treatment with drugs that are strong CYP3A inducers are excluded from the trial.
- Patients who require concurrent treatment with drugs that are strong to moderate CYP3A inhibitors are excluded from the trial.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY heart classification III/IV), unstable angina pectoris, cardiac arrhythmia, QTc...
- HIV-positive patients on combination antiretroviral therapy are ineligible. Patients with any active hepatitis infections. Presence of nyctalopia (night blindness), or hemeralopia (defective vision in a bright light...
- History of solid tumor malignancy other than the diseases under study, diagnosed within the last three (3) years of study enrollment, excluding adequately treated basal cell carcinoma of the skin, squamous cell...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.