DelfaGLP-1 Atlas

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WithdrawnPhase EARLY_1

Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study

Asset

Pramlintide

Amylin analog

Listed sites

1

Recruiting sites

—

Enrollment

—

actual

Study population

Oncology

Key I/E criterion

—

Primary endpoint

•Participant Compliance

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04252612
Org study IDMCC-19708

Timeline

Milestones

Study start2020-01-30actual
Study first posted2020-02-05actual
Primary completion2023-06-26actual
Study completion2023-06-26actual
Last update posted2023-06-28actual

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Oncology

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Histologically proven cutaneous squamous cell carcinoma. Mixed histologies (basaloid, spindle, sarcomatoid, etc.) are allowed if the pathology review favors squamous cell carcinoma as the majority component. Cancers of unknown primary sites are allowed if the clinical history and the site are highly suggestive of a skin cancer primary
•Tumor site must be amenable for surgical resection and accessible for pre-treatment biopsy
•Tumor site must be measurable by caliper measurements or by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 imaging - lesions must be ≥1 cm
•Eastern Cooperative Oncology Group (ECOG) ≤2 and be medically able to undergo surgical resection
•Laboratory Requirements: Hemoglobin ≥ 8 g/dl, Platelet count ≥ 50,000/dl, Serum Creatinine ≤ 1.5 mg/dL OR Glomular Filtration Rate (GFR) ≥ 40, Serum aspartate aminotransferase (AST) and alanine transaminase (ALT) < 2.5x ULN; Total Bilirubin < 1.5x ULN (for patients with documented history of Gilbert's syndrome, total bilirubin level should be < 3.0 X ULN)
•Ability to understand and willingness to sign a written informed consent document
•Patients with child bearing potential must be willing to use barrier protection to prevent pregnancy while on study therapy and up to 30 days after the last dose of pramlintide
•Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
•Patients must be willing to comply with the protocol for the duration of the treatment including daily sub-cutaneous (SQ) injections, biopsies, scheduled visits and examinations, radiologic studies, and surgical resection

Exclusion criteria

•Type I diabetes: Type II diabetics (DM2) on insulin are allowed, however, for those DM2 patients that are on short acting insulin, the insulin dose should be reduced 50% and need to have regular glucose monitoring (see section 6.2.1). Type II diabetics not on insulin will not be eligible.
•Patients with known gastroparesis
•Patients with known allergic reactions to pramlintide or its ingredients
•Pregnant women and/or nursing patients will be excluded from this study because of unknown risks to fetus or nursing infants
•Any serious or uncontrolled medical disorder that could interfere with the current study as deemed by the investigating physician
•Participation in any other clinical study using an investigational agent within 21 days of starting treatment on this protocol
•No prior chemotherapy, radiation, or other tumor directed therapy within 21 days prior of starting treatment on this protocol

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Participant Compliance

Time frame:at 14 days from on study date

threshold achievement, descriptive

Secondary/protocol endpoint

Number of Adverse Events

Time frame:at 44 days from on study date

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.