ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer

NCT06922539 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ST-001-020
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To determine the MTD of ST-001 (12.5mg/mL) for IV infusion in patients with SCLC

  To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ST-001 12.5 mg/mL for IV infusion (ST-001) in patients with Relapsed/Refractory SCLC when ST-001 is administered via 4-hour IV infusion daily for five consecutive days, q3weeks. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in \>33% of participants. DLTs are defined as any treatment-related Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0) Grade 3 or 4 adverse events.

  From enrollment to end of treatment is 3 weeks

Secondary Outcomes (9)

• To describe the toxicity profile of ST-001 in patients with SCLC

  From enrollment to end of treatment is 3 weeks

• To observe and record anti-tumor activity of ST-001 in patients with SCLC

  From enrollment to end of treatment is 3 weeks

• Objective Response Rate (ORR)

  From enrollment to end of treatment is 3 weeks

• Progression-free survival (PFS)

  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.

  From enrollment to end of treatment is 3 weeks

Study Arms (2)

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.

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).

Drug: Fenretinide

Interventions

Fenretinide DRUG

Intravenous administration

Also known as: ST-001

Standard Phase 1a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• SciTech Development, Inc.: lead

Study Sites (1)

University of Southern California

Los Angles, California, 90007, United States

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Recurrence

Interventions

Fenretinide; MAC-ST-001

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Ali Moiin, MD

  SciTech Development, Inc.

  STUDY DIRECTOR

Central Study Contacts

Louis M Scarmoutzos, Ph.D.

CONTACT

617-283-2182; lou@scitechdevelopment.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: April 10, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)