Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05329103
Recruitment Status : Not yet recruiting
First Posted : April 14, 2022
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
Peel Therapeutics Inc

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 solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: PEEL-224 Phase 1

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 (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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 2022
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Experimental: PEEL-224 Dose Escalation
PEEL-224 is administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. The study will begin at a low starting dose and will increase between cohorts according to mTPI-2 until a recommended phase 2 dose is determined. Approximately 10 dose levels are anticipated to be studied.
Drug: PEEL-224
Lyophilized powder reconstituted with D5W

Experimental: PEEL-224 Dose Confirmation
An additional arm of patients will be enrolled after dose escalation is completed to confirm the recommended phase 2 dose.
Drug: PEEL-224
Lyophilized powder reconstituted with D5W




Primary Outcome Measures :
  1. Determine maximum tolerated dose [ Time Frame: 28 days ]
    Frequency, severity, and relatedness of dose limiting toxicities


Secondary Outcome Measures :
  1. Overall safety and tolerability of PEEL-224 [ Time Frame: through study completion, expected average of 6 months ]
    Frequency, severity, and relatedness of AEs and SAEs

  2. Antitumor activity assessment [ Time Frame: every 8 weeks through study completion, expected average of 6 months ]
    based on RECIST 1.1

  3. Cmax of PEEL-224 and its metabolite [ Time Frame: Through 96 hours after dosing on Cycle 1 Day 1 and through 168 hours hours of dosing on Cycle 1 Day 15 ]
    maximum blood concentration of PEEL-224 and its metabolite

  4. Tmax of PEEL-224 and its metabolite [ Time Frame: Through 96 hours after dosing on Cycle 1 Day 1 and through 168 hours hours of dosing on Cycle 1 Day 15 ]
    Time to maximum blood concentration of PEEL-224 and its metabolite

  5. changes in QTcF/QTcBBB [ Time Frame: Through Cycle 1 (28 days) ]
    ECG parameter readings



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, including:
  • 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.
Layout table for additonal information
Responsible Party: Peel Therapeutics Inc
ClinicalTrials.gov Identifier: NCT05329103    
Other Study ID Numbers: PEEL-224-001
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms