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

NCT05329103 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PEEL-224-001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 7

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Determine maximum tolerated dose

  Frequency, severity, and relatedness of dose limiting toxicities

  28 days

Secondary Outcomes (5)

• Overall safety and tolerability of PEEL-224

  through study completion, expected average of 6 months

• Antitumor activity assessment

  every 8 weeks through study completion, expected average of 6 months

• Cmax 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

• Tmax 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

• changes in QTcF/QTcBBB

  Through Cycle 1 (28 days)

Study Arms (3)

Part 1A: PEEL-224 Dose Escalation

EXPERIMENTAL

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

Part 1B: PEEL-224 Dose Confirmation

EXPERIMENTAL

PEEL-224 is administered intravenously (IV) on Days 1 and 15 of a 28-day cycle at the dose determined in Part 1A

Drug: PEEL-224

Part 2: PEEL-224 plus FOLF+B

EXPERIMENTAL

PEEL-224 is administered intravenously (IV) and in combination with FOLFPB on Days 1 and 15 of a 28-day cycle. Up to 3 dose levels of PEEL-224 will be tested as determined by the results of Part 1.

Drug: PEEL-224; Drug: FOLF+B

Interventions

PEEL-224 DRUG

Lyophilized powder reconstituted with D5W

Part 1A: PEEL-224 Dose Escalation; Part 1B: PEEL-224 Dose Confirmation; Part 2: PEEL-224 plus FOLF+B

FOLF+B DRUG

infusional 5-FU, LV, and bevacizumab

Part 2: PEEL-224 plus FOLF+B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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 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.

Sponsors & Collaborators

• Peel Therapeutics Inc: lead

Study Sites (7)

HonorHealth Research Institiute

Scottsdale, Arizona, 85258, United States

RECRUITING

Stanford Cancer Center

Palo Alto, California, 94305, United States

RECRUITING

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

COMPLETED

Abramson Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

COMPLETED

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

COMPLETED

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 14, 2022
• Study Start: July 11, 2022
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)