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

Part of paid clinical trials in Los Angeles, California.

Sponsor
SciTech Development, Inc.
Study ID
NCT06922539
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fenretinide — DRUG
    Intravenous administration
  • Fenretinide — DRUG
    Intravenous administration

Study Details

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

Key Dates

First listed
Apr 10, 2025
Start date
Dec 11, 2025
Status verified
Jul 2026
Primary completion
May 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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).

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90007-

Find similar trials in Los Angeles, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Southern California· Los Angeles, CA

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