PRE-ISPY Phase I/II Oncology Platform Program
PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/II Platform Trial
QuantumLeap Healthcare Collaborative
280 participants
Feb 15, 2023
INTERVENTIONAL
Conditions
Summary
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced, incurable, or metastatic solid tumors and/or oligometastatic malignancy and/or a high risk of recurrence following prior treatment with curative intent. The overall goal is moving promising drug regimens into a larger phase II (or III) trial and in general could feed the neoadjuvant breast I-SPY 2 Trial (NCT01042379) and/or other oncology solid tumor trial in a timely manner.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Starting dose Dose Level 1 30mg/kg IV Q3W; Dose Level Minus 1 20 mg/kg IV Q3W (if needed); Dose Level 2 45 mg/kg IV Q3W;
5.4 mg/kg IV Q3W; allowed to dose reduce after DLT observation period
20 mg/kg IV Q2W on Day 1 and Day 15 of each 28 day cycle
Dose Level 1: 300 mg PO BID daily; Dose Leve Minus 1: 250 mg PO BID daily
4.8 mg/kg Q4W IV on Day 1 for up to 12 cycles as interception therapy
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05868226