PRE-I-SPY Phase I/Ib Oncology Platform Program

I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.

Trial Details

NCT ID
NCT05868226
Phase
PHASE1
Sponsor
QuantumLeap Healthcare Collaborative
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • ALX148
  • Fam-Trastuzumab Deruxtecan-Nxki
  • Zanidatamab
  • Tucatinib
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Tampa, Florida, United States|27.94752,-82.45843
  • Chicago, Illinois, United States|41.85003,-87.65005
  • New Lenox, Illinois, United States|41.51198,-87.96561
  • Orland Park, Illinois, United States|41.63031,-87.85394

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

For full eligibility, visit ClinicalTrials.gov.

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