Small Cell Lung CancerPhase 1NCT06922539
Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer
A Phase 1 study testing Fenretinide in people with Small Cell Lung Cancer, run by SciTech Development, Inc. at 2 sites in United States.
Trial summary
This study evaluates a fenretinide phospholipid suspension for the treatment of small cell lung cancer (SCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Fenretinide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Dec 2025to 1 Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
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- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Henry Ford Cancer Institute
Detroit, Michigan, 48202
Dalia Abdullah
Bindu R Potugari, M.D.
- Recruiting
University of Southern California
Los Angeles, California, 90007
Angelina Lee
Jacob S Thomas, M.D.
About this study
Official title: A Phase 1b Trial in Relapsed/Refractory Small Cell Lung Cancer to Determine the Clinical Activity, Safety Profile, and Pharmacology of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg/mL) for Intravenous Infusion
This study evaluates a fenretinide phospholipid suspension for the treatment of small cell lung cancer (SCLC).
Read the detailed description
Fenretinide has been shown to be a relatively safe and effective anticancer therapy; however, low fenretinide bioavailability and dose limiting toxicities due to excipients used in previous formulations has impeded its therapeutic utility. The product formulation in the current study (ST-001) is a phospholipid suspension of nanoparticle sized fenretinide. The current study is a Phase 1 trial in in relapsed/refractory small cell lung cancer to determine the clinical activity, safety profile, and pharmacology of ST-001.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Fenretinide
- Keywords
- fenretinide, SCLC, Relapsed/Refractory, Relapsed/Refractory SCLC, R/R SCLC, ST-001, intravenous administration
- Medical subject headings
- Small Cell Lung Carcinoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenretinideDrug
Also called ST-001
Intravenous administration
FenretinideDrug
Also called ST-001
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Standard Phase 1a | Experimental | During the Standard Phase 1a, three patients are enrolled into each dose level cohort and the three patients must be evaluated for cycle 1 toxicity before the decision can be made to open the next higher dose level. Receives: Drug: Fenretinide |
| Expanded Phase 1b | Experimental | Expansion of the dose-finding Phase 1a to determine the safety and maximum tolerated dose (MTD) of the investigative drug product (ST-001). Receives: Drug: Fenretinide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: From enrollment to end of treatment is 3 weeks
Secondary outcomes (8)
To describe the toxicity profile of ST-001 in patients with SCLC
Determine the number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: From enrollment to end of treatment is 3 weeks
To observe and record anti-tumor activity of ST-001 in patients with SCLC
Preclinical studies with fenretinide suggest potential efficacy against SCLC. Patients will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Objective Response Rate (ORR) and progression-free survival (PFS) will be used as tumor response endpoints in this study.
Measured: From enrollment to end of treatment is 3 weeks
Objective Response Rate (ORR)
ORR = (Number of patients with complete or partial response) / (Total number of evaluable patients) x 100. Minimum duration of individual patient participation is 3 weeks (one cycle of therapy) to be evaluable for response.
Measured: From enrollment to end of treatment is 3 weeks
To describe the pharmacokinetics of fenretinide when ST-001 is administered by daily infusion for 5 consecutive days every 3 weeks.
The endpoint for the pharmacokinetic studies is to assess fenretinide blood plasma levels as a function of administered dose and to determine the following PK parameters: maximum fenretinide concentration (Cmax), time of Cmax (Tmax), volume of distribution (Vd), clearance (CL), elimination and fenretinide half-life (t½).
Measured: From enrollment to end of treatment is 3 weeks
Cmax
Peak plasma fenretinide concentration (in ng/mL)
Measured: From enrollment to end of treatment is 3 weeks
Tmax
The time it takes for fenretinide to reach the maximum concentration (Cmax) after drug administration (in hours)
Measured: From enrollment to end of treatment is 3 weeks
Vd
Volume of distribution; fenretinide's propensity to either remain in the plasma or redistribute to other tissue compartments (in liters)
Measured: From enrollment to end of treatment is 3 weeks
t½
Fenretinide elimination and half-life; the time it takes for the amount of a drug's active substance in your body to reduce by half (hours)
Measured: From enrollment to end of treatment is 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start11 Dec 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SciTech Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ali Moiin, MD, Study director, SciTech Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922539
- Sponsor's protocol ID
- ST-001-020
- Status last verified
- Aug 2026
- First submitted
- 22 Mar 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Trial in Relapsed/Refractory Small Cell Lung Cancer to Determine the Clinical Activity, Safety Profile, and Pharmacology of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg/mL) for Intravenous Infusion
- ClinicalTrials.gov ID
- NCT06922539
- Acronym / sponsor ID
- ST-001-020
- Conditions
- Small Cell Lung Cancer
- Keywords
- fenretinide, SCLC, Relapsed/Refractory, Relapsed/Refractory SCLC, R/R SCLC, ST-001, intravenous administration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- SciTech Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a fenretinide phospholipid suspension for the treatment of small cell lung cancer (SCLC).
Detailed description
Fenretinide has been shown to be a relatively safe and effective anticancer therapy; however, low fenretinide bioavailability and dose limiting toxicities due to excipients used in previous formulations has impeded its therapeutic utility. The product formulation in the current study (ST-001) is a phospholipid suspension of nanoparticle sized fenretinide. The current study is a Phase 1 trial in in relapsed/refractory small cell lung cancer to determine the clinical activity, safety profile, and pharmacology of ST-001.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Phase 1a | Experimental | Drug: FenretinideDuring the Standard Phase 1a, three patients are enrolled into each dose level cohort and the three patients must be evaluated for cycle 1 toxicity before the decision can be made to open the next higher dose level. |
| Expanded Phase 1b | Experimental | Drug: FenretinideExpansion of the dose-finding Phase 1a to determine the safety and maximum tolerated dose (MTD) of the investigative drug product (ST-001). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FenretinideAlso: ST-001Intravenous administration | Drug | Standard Phase 1a |
| FenretinideAlso: ST-001Intravenous administration | Drug | Expanded Phase 1b |
Primary outcome
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.
Time frame: 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.
8 secondary outcomes
To describe the toxicity profile of ST-001 in patients with SCLC
Time frame: From enrollment to end of treatment is 3 weeks
To observe and record anti-tumor activity of ST-001 in patients with SCLC
Time frame: From enrollment to end of treatment is 3 weeks
Objective Response Rate (ORR)
Time frame: From enrollment to end of treatment is 3 weeks
To describe the pharmacokinetics of fenretinide when ST-001 is administered by daily infusion for 5 consecutive days every 3 weeks.
Time frame: From enrollment to end of treatment is 3 weeks
Cmax
Time frame: From enrollment to end of treatment is 3 weeks
Tmax
Time frame: From enrollment to end of treatment is 3 weeks
Vd
Time frame: From enrollment to end of treatment is 3 weeks
t½
Time frame: From enrollment to end of treatment is 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Moiin, MD study director
SciTech Development, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fenretinide in people with Small Cell Lung Cancer, run by SciTech Development, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louis M Scarmoutzos, Ph.D. (617-283-2182, lou@scitechdevelopment.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From enrollment to end of treatment is 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.