Evaluating PEEL-224 for advanced solid tumors
An Early Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of PEEL-224 in Patients With Advanced Solid Tumors
This study is testing a new drug called PEEL-224 to see if it is safe and effective for people with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peel Therapeutics Inc Industry-sponsored |
| Locations | 7 sites (Scottsdale, Arizona and 6 other locations) |
| Trial ID | NCT05329103 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, dose escalation, multi-center, open-label study assessing the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PEEL-224, a novel topoisomerase I inhibitor, in patients with advanced solid tumors. The study will utilize a modified toxicity probability interval-2 design to guide dose escalation, aiming for a target toxicity rate of 25%. Patients will be enrolled in cohorts and will complete Cycle 1 before advancing to higher dose levels. The trial seeks to provide insights into the drug's effectiveness and safety profile.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced or metastatic solid tumors that have progressed after standard therapy or for whom no approved standard therapy exists.
Not a fit: Patients with primary central nervous system tumors or untreated brain or spinal metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option for patients with advanced solid tumors that have limited therapeutic alternatives.
How similar studies have performed: While this approach is novel, similar studies evaluating new cancer therapies have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Scottsdale, Arizona and 6 other locations
- HonorHealth Research Institiute — Scottsdale, Arizona, United States (Recruiting)
- Stanford Cancer Center — Palo Alto, California, United States (Recruiting)
- Carolina BioOncology Institute — Huntersville, North Carolina, United States (Completed)
- Abramson Cancer Center at Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (Completed)
- Mary Crowley Cancer Research — Dallas, Texas, United States (Completed)
- Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (Recruiting)
- NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.