RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 PEEL-224 in patients with advanced solid tumors.

Official Title

An Early Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of PEEL-224 in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2022-07-11

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05329103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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.

Inclusion Criteria

Exclusion Criteria

* 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

* 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.

Contacts and Locations

Study Locations (Sites)

HonorHealth Research Institiute

Scottsdale, Arizona, 85258

United States

Stanford Cancer Center

Palo Alto, California, 94305

United States

Carolina BioOncology Institute

Huntersville, North Carolina, 28078

United States

Abramson Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106

United States

Mary Crowley Cancer Research

Dallas, Texas, 75230

United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112

United States

NEXT Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Peel Therapeutics Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-11

Study Completion Date2026-03

Study Record Updates

Study Start Date2022-07-11

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor