A Study to Evaluate PEEL-224 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Peel Therapeutics Inc
Study ID
NCT05329103
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • PEEL-224 — DRUG
    Lyophilized powder reconstituted with D5W
  • FOLF+B — DRUG
    infusional 5-FU, LV, and bevacizumab

Study Details

This is a first-in-human, dose escalation, repeat-dose, multi-center, open-label study evaluating safety, tolerability, PK, and preliminary antitumor activity of PEEL-224 in patients with advanced solid tumors.

Key Dates

Start date
Jul 11, 2022
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

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

Arms

  • Experimental: Part 1A: PEEL-224 Dose Escalation
    PEEL-224 is administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. The study will begin at a low starting dose and will increase between cohorts according to mTPI-2 until a recommended phase 2 dose is determined. Approximately 10 dose levels are anticipated to be studied.
  • Experimental: Part 1B: PEEL-224 Dose Confirmation
    PEEL-224 is administered intravenously (IV) on Days 1 and 15 of a 28-day cycle at the dose determined in Part 1A
  • Experimental: Part 2: PEEL-224 plus FOLF+B
    PEEL-224 is administered intravenously (IV) and in combination with FOLFPB on Days 1 and 15 of a 28-day cycle. Up to 3 dose levels of PEEL-224 will be tested as determined by the results of Part 1.

Primary Outcome Measure

Determine maximum tolerated dose [ Time Frame: 28 days ]

Locations (8)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstitiuteScottsdaleArizona85258
Oncology Nurse Navigator
[email protected]
480-323-1364
Erkut Borazanci, MD (PRINCIPAL_INVESTIGATOR)
Stanford Cancer CenterPalo AltoCalifornia94305-
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078-
Abramson Cancer Center at Pennsylvania HospitalPhiladelphiaPennsylvania19106-
Rhode Island HospitalProvidenceRhode Island02903
Stephan Sando
[email protected]
401-606-6602
Howard Safran, MD (PRINCIPAL_INVESTIGATOR)
Mary Crowley Cancer ResearchDallasTexas75230-
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112
Susan Sharry, CCRP
[email protected]
801-587-4488
Vaia Florou, MD (PRINCIPAL_INVESTIGATOR)
NEXT VirginiaFairfaxVirginia22031
Malaika Komtangi
[email protected]
210-580-9500
Alexander Spira, MD, PhD, FACP (PRINCIPAL_INVESTIGATOR)

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By research site
HonorHealth Research Institiute· Scottsdale, AZStanford Cancer Center· Palo Alto, CACarolina BioOncology Institute· Huntersville, NCAbramson Cancer Center at Pennsylvania Hospital· Philadelphia, PARhode Island Hospital· Providence, RIMary Crowley Cancer Research· Dallas, TX

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