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

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05329103
• Other study ID #: PEEL-224-001
• Status: Recruiting
• Phase: Phase 1
• Start date: July 11, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Peel Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 solid tumors.

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 (PEEL-224) in patients with advanced solid tumors. Dose escalation will be guided by the modified toxicity probability interval-2 (mTPI-2) design with a target toxicity rate of 25% and an acceptable DLT interval of 20% to 30%. Cohorts of 2 or more patients will be sequentially enrolled at progressively higher dose levels of PEEL-224. For each dose level, all patients must complete Cycle 1 before the decision to dose escalate the next cohort of patients is made.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• PEEL-224
Lyophilized powder reconstituted with D5W

Locations

Country	Name	City	State
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	NEXT Virginia	Fairfax	Virginia
United States	Carolina BioOncology Institute	Huntersville	North Carolina
United States	Stanford Cancer Center	Palo Alto	California
United States	Abramson Cancer Center at Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Huntsman Cancer Institute, University of Utah	Salt Lake City	Utah
United States	HonorHealth Research Institiute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Peel Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine maximum tolerated dose	Frequency, severity, and relatedness of dose limiting toxicities	28 days
Secondary	Overall safety and tolerability of PEEL-224	Frequency, severity, and relatedness of AEs and SAEs	through study completion, expected average of 6 months
Secondary	Antitumor activity assessment	based on RECIST 1.1	every 8 weeks through study completion, expected average of 6 months
Secondary	Cmax of PEEL-224 and its metabolite	maximum blood concentration of PEEL-224 and its metabolite	Through 96 hours after dosing on Cycle 1 Day 1 and through 168 hours hours of dosing on Cycle 1 Day 15
Secondary	Tmax of PEEL-224 and its metabolite	Time to maximum blood concentration of PEEL-224 and its metabolite	Through 96 hours after dosing on Cycle 1 Day 1 and through 168 hours hours of dosing on Cycle 1 Day 15
Secondary	changes in QTcF/QTcBBB	ECG parameter readings	Through Cycle 1 (28 days)