Recruiting
Phase 1

Fenretinide

Sponsor:

SciTech Development, Inc.

Code:

NCT06922539

Conditions

Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fenretinide

Fenretinide

Study Details

Brief summary:

This study evaluates a fenretinide phospholipid suspension for the treatment of small cell lung cancer (SCLC).

Conditions

Small Cell Lung Cancer

Study ID

NCT06922539

Start date

Dec 11, 2025

Status verified date

Aug, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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 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).

Study Design

Enrollment

44 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standard Phase 1a

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.

experimental: Expanded Phase 1b

Expansion of the dose-finding Phase 1a to determine the safety and maximum tolerated dose (MTD) of the investigative drug product (ST-001).

Interventions

Fenretinide

Intravenous administration

Fenretinide

Intravenous administration

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 ]

Central Contacts and Locations

Central contacts

Louis M Scarmoutzos, Ph.D.

617-283-2182lou@scitechdevelopment.com

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90007

Principal Investigator:

Jacob S Thomas, M.D.

Henry Ford Cancer Institute

Recruiting

Detroit, Michigan, United States, 48202

Principal Investigator:

Bindu R Potugari, M.D.

More Information

Sponsor

SciTech Development, Inc.

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • fenretinide
  • SCLC
  • Relapsed/Refractory
  • Relapsed/Refractory SCLC
  • R/R SCLC
  • ST-001
  • intravenous administration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SciTech Development, Inc. on 2026-08-19.