PRE-ISPY Phase I/II Oncology Platform Program

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

Trial Details

NCT ID
NCT05868226
Phase
PHASE1 / PHASE2
Sponsor
QuantumLeap Healthcare Collaborative
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • ALX148
  • Fam-Trastuzumab Deruxtecan-Nxki
  • Zanidatamab
  • Tucatinib
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Tampa, Florida, United States|27.94752,-82.45843
  • Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility Criteria

  • GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessm…
  • GIC2: Age ≥ 18 years at the time of signing the informed consent
  • GIC3: Gender: Male or female (premenopausal and postmenopausal)
  • GIC4: ECOG performance status Grade 0-2. This criteria can be modified in specific drug regimens.

For full eligibility, visit ClinicalTrials.gov.

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