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Phase 1 Trial of ST-001 nanoFenretinide for Small Cell Lung Cancer

This study is testing a new form of a drug called ST-001 nanoFenretinide, which uses tiny particles (nanoparticles) to deliver the medicine, for people with small cell lung cancer (SCLC). This drug works by using an immunotherapy mechanism. You may be able to join if you have SCLC that has come back or hasn't responded to previous treatments, including platinum-based chemotherapy, and you have at least one measurable tumor. The main goal is to see how long people live without their cancer growing (progression-free survival) when treated with ST-001. The study is currently unclear about its recruitment status and plans to enroll 44 participants.

Study design
This is a Phase 1 interventional study, meaning it's an early-stage trial to test a new treatment. It plans to enroll 44 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, progression-free survival, is measured from enrollment to the end of treatment, which is 3 weeks.

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

NCT06922539

Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
SciTech Development, Inc.
~44 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Fenretinide

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the progression-free survival (PFS) of patients with relapsed or refractory small-cell lung cancer (SCLC) who are treated with ST-001 after receiving at least one prior systemic therapy.
Measured over From enrollment to end of treatment is 3 weeks

Conditions

Small Cell Lung Cancer

Explore related trials

Lung Small Cell Carcinoma

Where it's being run

2 sites across 2 states
California1
Michigan1

Study leadership

  • Ali Moiin, MD · STUDY_DIRECTOR · SciTech Development, Inc.

Who to contact

Louis M Scarmoutzos, Ph.D.
[email protected]
617-283-2182
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 radiation treatment. Patients must have recovered from all clinically significant 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

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).

What this trial measures

  • To evaluate the progression-free survival (PFS) of patients with relapsed or refractory small-cell lung cancer (SCLC) who are treated with ST-001 after receiving at least one prior systemic therapy.From enrollment to end of treatment is 3 weeks

    Evaluate progression-free survival (PFS) in patients with relapsed or refractory small-cell lung cancer (SCLC) after prior platinum-based chemotherapy ± immunotherapy who are treated with ST-001 (12.5mg/mL) for IV Infusion, using a Simon 2-stage study design with an interim analysis for futility. PFS is defined as the time from start of treatment to disease progression (increase in tumor size, new metastases) or death.