PRE-ISPY Phase I/II Oncology Platform Program
Sponsor: QuantumLeap Healthcare Collaborative • ClinicalTrials.gov ID: NCT05868226
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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.
Interventions
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ALX148
(Drug)
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;
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Fam-Trastuzumab Deruxtecan-Nxki
(Drug)
5.4 mg/kg IV Q3W; allowed to dose reduce after DLT observation period
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Zanidatamab
(Drug)
20 mg/kg IV Q2W on Day 1 and Day 15 of each 28 day cycle
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Tucatinib
(Drug)
Dose Level 1: 300 mg PO BID daily; Dose Leve Minus 1: 250 mg PO BID daily
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TTX-MC138
(Drug)
4.8 mg/kg Q4W IV on Day 1 for up to 12 cycles as interception therapy
Eligibility criteria
Conditions
Locations
- The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center — Birmingham, Alabama, United States
- Mayo Clinic Comprehensive Cancer Center — Phoenix, Arizona, United States
- University of Colorado Cancer Center — Aurora, Colorado, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- The University of Chicago Medicine Comprehensive Cancer Center — Chicago, Illinois, United States
- UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital — New Lenox, Illinois, United States
- UChicago Medicine Orland Park — Orland Park, Illinois, United States
- University of Minnesota Masonic Cancer Center — Minneapolis, Minnesota, United States
- Mayo Clinic Comprehensive Cancer Center — Rochester, Minnesota, United States
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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