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Status:

RECRUITING

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

Lead Sponsor:

Peel Therapeutics Inc

Conditions:

Advanced Solid Tumor

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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 sol...

Detailed Description

This is a first-in-human, dose escalation, repeat-dose, multi-center, open-label study evaluating safety, tolerability, PK, and preliminary antitumor activity of a novel topoisomerase I inhibitor (PEE...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Have a diagnosis of colorectal cancer confirmed by local pathology review (histology or cytology) - Part 2 only
  • ECOG of 0 or 1
  • Have a diagnosis of advanced or metastatic solid tumor that has progressed after prior standard therapy, have been intolerant or ineligible for standard therapy, or have a malignancy for which there is no approved therapy considered standard of care
  • Have at least 1 documented measurable lesion as detected by radiological methods at study entry as per Response Evaluation Criteria in Solid Tumors v1.1
  • Have adequate bone marrow reserve
  • Have adequate liver function
  • Have adequate renal function
  • Have completed prior anticancer therapy, including investigational agents, ≥28 days or 5 half lives, whichever is shorter, prior to study treatment
  • Have resolution of any clinically significant toxic effects of prior therapy
  • Exclusion criteria:
  • Have primary central nervous system tumors
  • Have brain or spinal metastases, except if treated by surgery, surgery plus focal radiotherapy, or radiotherapy alone, with no evidence of progression or hemorrhage ≤14 days prior to the first dose of PEEL-224. Have craniospinal radiotherapy ≤12 weeks prior to the first dose of PEEL-224
  • Have significant abnormalities in the level of serum electrolytes
  • Have received neutrophil growth factor support ≤14 days prior to the first dose of PEEL 224
  • Have an active infection ≤14 days prior to the first dose of PEEL-224
  • Use of strong cytochrome P450 (CYP)1A2 and CYP3A4 inhibitors and/or inducers ≤14 days prior to the first dose of PEEL-224 or during the study
  • Use of systemic corticosteroids ≤14 days prior to the first dose of PEEL-224
  • Are known to be HIV-positive, unless CD4 + lymphocyte count ≥ 300/μL, undetectable viral load; AND Receiving anti-retroviral therapy.
  • Have uncontrolled hepatitis B infection or hepatitis C infection;
  • Are pregnant or lactating, plan to become pregnant, or plan to donate gametes (ova or sperm) for in vitro fertilization during the study period or for 90 days after the patient's last study-related visit (for eligible patients only, if applicable). Eligible female patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy does not occur during the study will be excluded;
  • Have evidence of another malignancy ≤2 years prior to screening (except in situ non melanoma skin cell cancers and in situ cervical carcinoma);
  • Are currently enrolled in another therapeutic clinical study or a non-therapeutic clinical study that will conflict with scheduled visits required by this study;
  • Have clinically significant, uncontrolled cardiovascular disease
  • Have history of cerebrovascular accident, transient ischemic attack, or thrombosis requiring treatment ≤3 months prior to the first dose of PEEL-224
  • Have received or will receive a live vaccine ≤14 days prior to the first dose of PEEL 224.
  • Have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection ≤14 days of the Screening Visit.

Exclusion

    Key Trial Info

    Start Date :

    July 11 2022

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 1 2026

    Estimated Enrollment :

    65 Patients enrolled

    Trial Details

    Trial ID

    NCT05329103

    Start Date

    July 11 2022

    End Date

    March 1 2026

    Last Update

    June 17 2025

    Active Locations (7)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (7 locations)

    1

    HonorHealth Research Institiute

    Scottsdale, Arizona, United States, 85258

    2

    Stanford Cancer Center

    Palo Alto, California, United States, 94305

    3

    Carolina BioOncology Institute

    Huntersville, North Carolina, United States, 28078

    4

    Abramson Cancer Center at Pennsylvania Hospital

    Philadelphia, Pennsylvania, United States, 19106