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Recruiting Phase 1 NCT05329103

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

Trial Parameters

Condition Advanced Solid Tumor
Sponsor Peel Therapeutics Inc
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 65
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-07-11
Completion 2025-12
Interventions
PEEL-224FOLF+B

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.

Eligibility Criteria

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 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 treat

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