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New treatment option for Advanced Solid Tumor
Official title A Study to Evaluate PEEL-224 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05329103
What this study is testing
What is PEEL-224?
PEEL-224 is an investigational medicine, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Have at least 1 documented measurable lesion as detected by radiological methods at study entry as per Response Evaluation Criteria in Solid Tumors...
- Have adequate bone marrow reserve
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Palo Alto, California, United States
- Huntersville, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Palo Alto, California, United States; Huntersville, North Carolina, United States; Philadelphia, Pennsylvania, United States; Providence, Rhode Island, United States; Dallas, Texas, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.