Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PEEL-224 · 1 trial · 1 indication
Frequency, severity, and relatedness of dose limiting toxicities
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| Name | Type | Description |
|---|---|---|
| PEEL-224 | DRUG | Lyophilized powder reconstituted with D5W |
| FOLF+B | DRUG | infusional 5-FU, LV, and bevacizumab |
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 st...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
PEEL-224 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, meaning it is being studied for safety and dosing in patients with advanced solid tumors, but it is not yet approved for any use.
PEEL-224 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the drug in patients with advanced solid tumors.
PEEL-224 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients to evaluate the drug's safety and tolerability in advanced solid tumors.
PEEL-224 is being studied in a Phase 1 clinical trial with the identifier NCT05329103, titled "A Study to Evaluate PEEL-224 in Patients With Advanced Solid Tumors." This trial is currently recruiting participants in the United States and aims to enroll 65 patients aged 18 years and older.
PEEL-224 is a small molecule being studied in a biomarker-selected patient population, meaning the trial may enroll patients based on specific biomarkers. However, the specific molecular target of PEEL-224 has not been disclosed in the available information.