NCT06709495 · David S Shulman, MD
Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas
What this study is about
This research is being done to test a new drug called PEEL-224 in combination with two commercially available drugs, Vincristine and Temozolomide, and to determine how effective this combination of drugs is at treating Ewing Sarcoma (EWS) and Desmoplastic Small Round Cell Tumor (DSRCT), as well as multiple other kinds of sarcomas.
View original scientific description
This research is being done to test a new drug called PEEL-224 in combination with two commercially available drugs, Vincristine and Temozolomide, and to determine how effective this combination of drugs is at treating Ewing Sarcoma (EWS) and Desmoplastic Small Round Cell Tumor (DSRCT), as well as multiple other kinds of sarcomas.
Interventions
DRUG
PEEL-224
Topoisomerase 1 inhibitor, 200mg amber vial, via intravenous (into the vein) infusion per protocol.
DRUG
Temozolomide
Alkylating agent, 5, 20, 100, 140, 180, or 250 mg capsule, taken orally per standard of care.
DRUG
Vincristine
Vinca alkaloid, 1 or 2mL vials, via intravenous (into the vein) infusion per institutional policy.
BIOLOGICAL
Pegfilgrastim
Myeloid growth factor administered per institutional standards.
BIOLOGICAL
Filgrastim
Myeloid growth factor administered per institutional standards.
Primary outcome measures
Maximum Tolerated Dose (MTD) (Phase 1)
Time frame: Up to 35 days
The MTD is determined by a Continual Reassessment Method (CRM) design and defined as the dose level with the posterior probability of dose-limiting toxicity (DLT) closest to the target toxicity rate of 0.3 with a maximum sample size of 15. The DLT observation period is up to 35 days long, beginning at the first dose of any of the three drugs in cycle 1 and ending at the occurrence of a DLT.
Number of Participants with Dose-Limiting Toxicities (Phase 1)
Time frame: Up to 35 days
Any ≥ Grade 2 CTCAE v5 adverse events that are possibly, probably, or definitely attributable to the combination of Vincristine, PEEL-224, and Temozolomide and within the first 35 days, beginning at the first dose of any of the three drugs in cycle 1 and ending at the occurrence of DLT or at the start of treatment in cycle 2 (whichever occurs first). To be evaluable for dose-limiting toxicity, a participant must also receive at least 75% of prescribed agents in cycle 1 and be followed for at least 35 days during cycle 1 or to the start of cycle 2 (whichever occurs first).
Number of Participants with DLTs (Phase 2)
Time frame: Up to 35 days
A safety monitoring rule will be applied to Phase 2 of the study for the overall participant cohort. The DLT observation period is up to 35 days long, beginning at the first dose of any of the three drugs in cycle 1 and ending at the occurrence of DLT or at the start of treatment in cycle 2 (whichever occurs first).
Objective Response Rate EWS Cohort (Phase 2)
Time frame: Up to 5 years (based on accrual duration of 2 years)
ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Evaluable participants must have measurable disease at screening, be treated at RP2D dose, have received at least one dose of study drug, and either have evidence of clinical progression or have had at least one follow-up disease evaluation of their RECIST measurable disease after initiation of protocol therapy. The proportion of responders is calculated as the (number of responders) / (number of evaluable participants).
Objective Response Rate DSRCT Cohort (Phase 2)
Time frame: Up to 5 years (based on accrual duration of 2 years)
ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Evaluable participants must have measurable disease at screening, be treated at RP2D dose, have received at least one dose of study drug, and either have evidence of clinical progression or have had at least one follow-up disease evaluation of their RECIST measurable disease after initiation of protocol therapy. The proportion of responders is calculated as the (number of responders) / (number of evaluable participants).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- -Patients in all cohorts must have relapsed or refractory disease after standard therapy. Inclusion Criteria Phase 1 (only) diagnosis requirements: -Patients must have:
- Evaluable or measurable disease; and
- Histologic diagnosis of sarcoma Inclusion Criteria Phase 2 (only) diagnosis requirements
- EWS cohort: Patients must have:
- RECIST measurable disease at study entry;
- Histologic diagnosis consistent with Ewing sarcoma; and
- Molecular evidence of a FET-ETS family translocation including but not limited to any of the following:
- EWSR1::FLI1, EWSR1::ERG, EWSR1::ETV1, EWSR1::ETV4, EWSR1::FEV, FUS::FLI1, FUS::ERG
- DSRCT cohort: Patients must have:
- RECIST measurable disease at study entry;
- Histologic diagnosis consistent with DSRCT; and
- Molecular evidence of an EWSR1::WT1 fusion
- Other sarcoma cohort: Patients must have:
- RECIST evaluable or measurable disease; and
- Histologic diagnosis of sarcoma. Patients with EWS or DSR
Where
- Boston, Massachusetts
Collaborators
Peel Therapeutics Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 19, 2026 · Source of record for eligibility and locations