Nano-formulated fenretinide for relapsed or refractory small cell lung cancer
A Phase 1a/1b Trial in Relapsed/Refractory Small Cell Lung Cancer to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg/mL) for Intravenous Infusion
This trial will test a nanoparticle phospholipid formulation of fenretinide to see if it can be given safely and help people whose small cell lung cancer has returned or not responded to prior treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SciTech Development, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Los Angles, California) |
| Trial ID | NCT06922539 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, open-label dose-escalation trial of ST-001, a phospholipid suspension of nanoparticle-sized fenretinide, in patients with relapsed or refractory small cell lung cancer. The study aims to characterize safety, pharmacokinetics, and to determine the maximum tolerated dose. Eligible patients must have measurable disease by RECIST 1.1, prior platinum-based chemotherapy ± immunotherapy or radiation, ECOG 0–1, and adequate organ function. Treatment and follow-up visits are conducted at the University of Southern California site.
Who should consider this trial
Good fit: Adults with relapsed or refractory small cell lung cancer who have at least one measurable tumor, ECOG performance status 0–1, adequate organ and marrow function, and who are at least four weeks out from prior therapy are appropriate candidates.
Not a fit: Patients with poor performance status, impaired organ function, fasting triglycerides ≥300 mg/dL, or those eligible for curative-intent therapy are unlikely to benefit from this Phase 1 trial.
Why it matters
Potential benefit: If successful, the nano-formulated fenretinide could improve drug delivery and tolerability, offering a new treatment option for patients with relapsed or refractory SCLC.
How similar studies have performed: Fenretinide has demonstrated anticancer activity in prior trials but has been limited by poor bioavailability and formulation-related toxicities, and the nanoparticle phospholipid formulation used here is a novel approach not yet proven in relapsed/refractory SCLC.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 had prior treatment with radiation therapy or with platinum-based chemotherapy ± immunotherapy with 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 4 weeks must have elapsed since last systemic treatment or radiation therapy treatment (or 6 weeks for any nitrosourea-containing regimens), and patients must have recovered from all toxicity of last treatment and cleared the pharmacological agent(s) used previously. * 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. Exclusion Criteria: * 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 to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * 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 treatment with radiotherapy, and patient is either no longer taking corticosteroids or on a stable dose of corticosteroids. * 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 interval \>450 milliseconds for men and \>460 milliseconds for women on baseline triplicate ECG, or psychiatric illness/social situations that would limit compliance with study requirements. * 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, 'day blindness') at enrollment, or any other retinal, ophthalmological condition (e.g.: retinitis pigmentosa, choroidoretinitis and xerophthalmia), and glaucoma. * 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 carcinoma of the skin, or in situ cervical cancer, in situ breast cancer, in situ prostate cancer (patients must have shown no evidence of active disease for 2 years prior to enrollment).
Where this trial is running
Los Angles, California
- University of Southern California — Los Angles, California, United States (Recruiting)
Study contacts
- Study coordinator: Louis M Scarmoutzos, Ph.D.
- Email: lou@scitechdevelopment.com
- Phone: 617-283-2182
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.